CTRI

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CTRI Number

CTRI/2025/06/089346 [Registered on: 23/06/2025] Trial Registered Prospectively

Last Modified On:

21/03/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Study to compare the efficacy, safety and immunogenicity of aflibercept intravitreal injection and Eylea (Aflibercept) intravitreal injection in patients with Diabetic Macular Oedema (DME)

Scientific Title of Study

A Phase-3, Double-Masked, Two-Arm, Multiple Dose, Parallel Group, Randomized, Multicentre, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Aflibercept Intravitreal Injection and Eylea (Aflibercept) Intravitreal Injection in Patients with Diabetic Macular Oedema (DME)

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
Protocol Number: 0252-24, Version: 2.1, Dated: 10-Mar-2025	Protocol Number

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Naman Shah
Designation	Associate Vice President
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India Ahmadabad GUJARAT 382481 India
Phone	07940202389
Fax	07940202021
Email	namanshah@lambda-cro.com

Details of Contact Person
Scientific Query

Name	Dr Jogesh Mahajan
Designation	Senior Vice President
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India Ahmadabad GUJARAT 382481 India
Phone	07940202288
Fax	07940202021
Email	jogeshmahajan@lambda-cro.com

Details of Contact Person
Public Query

Name	Dr Jogesh Mahajan
Designation	Senior Vice President
Affiliation	Lambda Therapeutic Research Ltd
Address	Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club,S. G. Highway, Gota, Ahmadabad, Gujarat, India Ahmadabad GUJARAT 382481 India
Phone	07940202288
Fax	07940202021
Email	jogeshmahajan@lambda-cro.com

Source of Monetary or Material Support

Intas Pharmaceuticals Ltd, Corporate Office, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad, Gujarat, India - 380054

Primary Sponsor

Name	Intas Pharmaceuticals Limited
Address	Corporate House, Near Sola Bridge, S.G. Highway, Thaltej, Ahmedabad, Gujarat, India. Pincode- 380054
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NA	NA

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 35
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Vishali Gupta	Advanced Eye Center, PGIMER	Department of Clinical research, Room No. NA, Advanced Eye Center, PGIMER, Room No- 242, Second Floor, Sector 12-160012, Chandigarh Chandigarh CHANDIGARH	8219916282 vishalisara@yahoo.co.in
Dr Ruchi Mehta	Advanced Retina Care	404-405, Aagam Avenue, Near Adani Gas Station, Opp. Motera BRTS Stand, Sabarmati Visat Road, Motera-380005, Ahmedabad, Gujarat, India Ahmadabad GUJARAT	9428154491 drruchimehta2012@gmail.com
Dr Obuli Ramachandran	CENTRE FOR SIGHT EYE INSTITUTE	Department of Clinical research, Room No. NA, Centre For Sight, Eye Hospital, B-5/24, Safdarjung Enclave, Opp. Deer Park, New Delhi - 110029" New Delhi DELHI	9600070925 dr.obuliramachandran@gmail.com
Dr Anup Shah	Chopda Medicare & Research Centre pvt Ltd	Department of Clinical research, Room No. NA, Mangnum Heart Institute, 3/5 Patil Lane No.1, Laxmi Nagar, Near K B H Vidyalaya, Canada Corner , Nashik-422005, Maharashtra, India Nashik MAHARASHTRA	9850501495 dranupshah@gmail.com
Dr Prakash V S	Comtrust Charitable Trust Eye Hospital	Department of Clinical research, Room No. NA, Mini Bypass Road, Puthiyara PO, Calicut-673004, Kerala , India Kozhikode KERALA	977842559 prakashvresearch@gmail.com;
Dr Nilesh Giri	D Y Patil Medical College, Hospital & Research Centre	Department of Clinical research, Room No. NA, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018. Pune MAHARASHTRA	9284528896 nilesh.giri@dpu.edu.in
Dr Punit Singh	Dhiraj Hospital	Department of Ophthalmology, Dhiraj Hospital, SVDU, Piparia, Ta. Waghodia, Vadodara-391760 Gujarat, India Vadodara GUJARAT	9879946599 punitsinghdr@gmail.com
Dr Debdulal Chakraborty	Disha Eye Hospitals Pvt Ltd	Department of Clinical research, Room No. NA, 14, gand Trunk road, Sheoraphuli, West Bengal -712223 Hugli WEST BENGAL	9433059923 devdc@rediffmail.com
Dr Atul Sahu	Dr. Agarwals Healthcare Limited	Department of Clinical research, Room No. NA, D 63/10, B-1A, Dayal Enclave , Mahmoorganj Varanasi-221010, Uttar Pradesh , India Varanasi UTTAR PRADESH	8808069485 atulkrsahu@gmail.com
Dr Manoj Khatri	Dr. Agarwal’s Eye Hospital	Department of Clinical research, Room No. NA, 222, TTK Road, Alwarpet, Chennai-600018 Chennai TAMIL NADU	8220287800 drmanojkhatri@gmail.com
Dr Nilesh Chakne	Dr. Chakne Eye nd Children Hospital	Department of Clinical research, Room No. NA, 204 2nd floor, Ganesham E commercial complex, Near Govind Yashada Chowk, Bhosari, Pimple Saudagar, BRTS Road, Pune- 411027 Pune MAHARASHTRA	7875989088 drnileshchakne@gmail.com
Dr Vinod Kumar	Dr. Rajendra Prasad Centre for Ophthalmic Sciences	Department of Clinical research, Room No. NA, AIIMS Campus , Sri Aurobindo Marg, Ansari Nagar East. New Delhi -110029, India New Delhi DELHI	9868420620 drvinod_agg@yahoo.com
Dr Rashmi Kashikar	H. V Desai EYE Hospital	Department of Clinical research, Room No. NA, 93, Tarawade Vasti, Mohammadwadi Hadapsar, Pune-411060 Pune MAHARASHTRA	020-26974117 kashikar.rashmi@gmail.com
Dr Bhavik Zala	Jyoti Eye Hospital	Department of Clinical research, Room No. NA, 305-307, 3rd Floor, Arjun Iconic, B/H Rana Park bus stand, Opp. Satya-2 Complex, Narayanpura, Ahmedabad-380013, Ahmadabad GUJARAT	9727717184 bhavikczala@gmail.com
Dr Anand Subramanyam	K B Haji Bachooali Charitable Ophthalmic & E.N.T Hospital	Department of Clinical research, Room No. NA, Free Ophthalmic Hospital Societys, 58/60 Jehangir Merwanji street, Parel, Mumbai, 400012, Maharashtra, India Mumbai MAHARASHTRA	9820800018 mumbairetinadoc@gmail.com
Dr Sanghamitra Kanungo	Kar Vision Eye Hospital	Department of Clinical research, Room No. NA, Plot no 10, Janpath, Satyanagar, Bhubaneswar, Odisha - 751007 Khordha ORISSA	9437002130 drskanungo@gmail.com
Dr Bibhuti Kashyap	Kashyap Memorial Eye Hospital Pvt Ltd	Department of Clinical research, Room No. NA, Purulia Rd, near Dangratoli Chowk, Dangratoli, Nayatoli Ranchi, (Jharkhand) 834001, India Ranchi JHARKHAND	9811826765 drbibhutipkashyap@gmail.com
Dr Ashish Sharma	Lotus Eye Hospital and lnstitute Limited	Department of Clinical research, Room No. NA, 770112, Avinashi Road, Civil Aerodrome Post, Coimbatore-641 014, Tamilnadu, India. Coimbatore TAMIL NADU	8144973937 drashish79@hotmail.com
Dr Somesh Aggarwal	M & J Western Regional Institute Of Ophthalmology	Department of Clinical research, Room No. NA, A Unit Of B J Medical College And Civil Hospital, Badiya Limbdi Char Rasta, New Civil Hospital Campus, Asarwa, Ahmedabad-380016,Gujarat,India Ahmadabad GUJARAT	9427029044 dr.somesh@yahoo.com
Dr Rohit Sanjay Laul	Modern Eye Hospital	Department of Clinical research, Room No. NA, 13G, Suyojit Modern Point, Sharanpur Rd, opposite Police Pared Ground, Nashik, Maharashtra 422002, India Nashik MAHARASHTRA	9656442160 drlaulrs@gmail.com
Dr Naresh Yadav	Narayana Nethralaya	Department of Clinical research, Room No. NA, 121/C, Chord Road, 1st R Block Rajaji Nagar, Bangalore, Karnataka- 560010 Bangalore KARNATAKA	9980872120 vasudha.naresh@gmail.com
Dr Sri Bhargava Natesh	Nethra Eye Hospital	Department of Clinical research, Room No. NA, No.8, 80 feet road, Poojaray Layout, RMV 2nd Stage, Sanjayagar, Bangalore-560094 Bangalore KARNATAKA	9342880273 sribhargava.natesh@gmail.com
Dr Parth Rana	Netralaya Super Speciality Eye Hospital	Department of Clinical research, Room No. NA, 1st Floor, Kaydee House ,Above Union bank of India, Opp. Gujarat gas, Parimal garden, Cross road, CG Road, Ahmedabad-380006, Gujarat, India Ahmadabad GUJARAT	7557777755 netralaya.rch@gmail.com
Dr Rupak Kanti Biswas	Netralayam-The Superspeciality Eye care Centre	Department of Clinical research, Room No. NA, Shree Tower II, 2nd Floor ,RAA 36, Raghunathpur, VIP road, Kolkata, 700059, West Bengal India Kolkata WEST BENGAL	8420211222 rkbstudy@gmail.com
Dr Mudit Bansal	Netralok Retina Clinic	Department of Clinical research, Room No. NA, 304/305 Golden Icon, Above Hyundai Showroom, Opp. Medilink Hospital, Nr. Shyamal Cross road, 132 Feet ring road, Setellite , Ahmedabad-15, Gujarat, India Ahmadabad GUJARAT	9427045076 drmudhitbansal@gmail.com
Dr Abhishek Dixit	Netrodaya - The Eye City	Department of Clinical research, Room No. NA, Arazi No – 561 & 562, NH-2, Dafi Toll Plaza, Varanasi – 221011 Uttar Pradesh Varanasi UTTAR PRADESH	9919106094 abhishekdixitcr@gmail.com
Dr Abhishek Dixit	Netrodaya - The Eye City	Department of Clinical research, Room No. NA, Arazi No – 561 & 562, NH-2, Dafi Toll Plaza, Varanasi – 221011 Varanasi UTTAR PRADESH	9919106094 abhishekdixitcr@gmail.com
Dr Urmil Shah	P. N. Desai Eye & ENT Hospital	Department of Clinical research, Room No. NA, 4 L. K. Society, B/H Sunset Row House, Next to Sterling Hospital, Gurukul Road, Memnagar, Ahmedabad-380052 Ahmadabad GUJARAT	9924738885 urmilmshah2010@gmail.com
Dr Abhishek Anand	Regional Institute Of Ophthalmology Indira Gandhi Institute Of Medical Sciences	Department of Clinical research, Room No. NA, Sheikhpura, Patna-800014, Bihar, India Patna BIHAR	8294777993 drabhishekrio@gmail.com
Dr Soumyadeep Majumdar	Regional Institute Of Opthalmology Medical College & Hospital	Department of Clinical research, Room No. NA, 88, College Street, Kolkata 700073, West Bengal, India Kolkata WEST BENGAL	9647683105 soumyanbmc@gmail.com
Dr Alok Sen	Sadguru Netra Chikitsalaya	Department of Clinical research, Room No. NA, Shri Sadguru Seva Sangh Trust Jankikund, Chitrakoot - 210204 Chhatarpur MADHYA PRADESH	7898201605 draloksen@gmail.com
Dr payal Shah	Sankara Eye Hospital	Department of Clinical research, Room No. NA, Varthur Main Road, KundanahalliGate, Bangalore,Karnataka,India 560037 Bangalore KARNATAKA	8088506150 payalnaresh@sankaraeye.com
Dr Sharad Bhomaj	Shanti Saroj Netralaya A. N Gaikwad	Department of Clinical research, Room No. NA, 901/902, Beside Sundar Nagar, Anand Nursing Home road, off, Sangli, Miraj, Maharashtra- 416410 Sangli MAHARASHTRA	7498337791 sharadbhomaj@gmail.com
Dr Shobhana Mange	Shivam Retina Clinic and eye Hospital	Department of Clinical research, Room No. NA, HG-1 A, ITC Building, Majura Gate, Ring Road, Surat- 395001 Gujarat, India Surat GUJARAT	9979530073 drshobhanamange@gmail.com
Dr Rushikesh Naigaonkar	Shri Ganapati Netralaya	Department of Clinical research, Room No. NA, Survey No. 204, 2, Devalgaonraja Mantha Road, Old MIDC, Jalna, Maharashtra 431203 Jalna MAHARASHTRA	9620842069 md@netralaya.org

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 34
Name of Committee	Approval Status
Centre For Sight Institutional Ethics Committee, Dr. Obuli Ramachandran	Approved
Disha Eye Hospitals Pvt Ltd Ethics Committee, Dr. Debdulal Chakraborty	Approved
Dr Agarwals Eye Hospital IEC, Dr. Manoj Khatri	Submittted/Under Review
Ethics committee Instutional Review Board, Dr. payal Shah	Approved
Ethics Committee,Dr.D.Y.Patil Vidyapeeth, Dr. Nilesh Giri	Submittted/Under Review
FOHSS Institutional Ethics Committee, Dr. Anand Subramanyam	Approved
IEC-Saishwari Clinic Hospital for mental Health, Dr. Sharad Bhomaj	Approved
Institutional Ethics Committee, Ashwin Hospital, Dr. Ashish Sharma	Approved
Institutional Ethics Committee All India Institute of Medical Sciences, Dr. Vinod Kumar	Approved
Institutional Ethics Committee Comtrust Charitable Trust Eye Hospital Puthiyara, Dr. Prakash V S	Approved
Institutional Ethics Committee for Human Research, Dr. Soumyadeep Majumdar	Submittted/Under Review
Institutional Ethics Committee Indira Gandhi Institute of Medical Sciences, Dr. Abhishek Anand	Submittted/Under Review
Institutional Ethics Committee PBMAs H V Desai Eye Hospital, Dr. Rashmi Kashikar	Approved
Institutional Ethics Committee, SV Sumandeep Vidyapeeth, Dr. Punit Singh	Approved
Institutional Ethics Committee-B J Medical College Of Civil Hospital, Dr. Somesh Aggarwal	Submittted/Under Review
Kar Vision Institutional Ethics Committee, Dr. Sanghamitra Kanungo	Approved
Kashyap Memorial Eye Hospital Ethics Committee, Dr. Bibhuti Kashyap	Approved
lnstitutional Ethics Committee, Post Graduate lnstitute of Medical Education and Research, Dr. Vishali Gupta	Approved
Magna-care Ethics Committee, Dr. Anup Shah	Submittted/Under Review
Narayana Nethralaya Ethics Committee, Dr. Naresh Yadav	Approved
Netralayam Ethics Committee, Dr. Rupak Kanti Biswas	Approved
Ojas Multispeciality Hospital Ethics Committee, Dr. Nilesh Chakne	Approved
Pranav Diabetes Centre Ethics Committee, Dr. Sri Bhargava Natesh	Approved
Riddhi Medical Nursing Home IEC, Dr. Ruchi Mehta	Approved
Sangini Hospital Ethics Committee, Dr. Bhavik Zala	Submittted/Under Review
Sangini Hospital Ethics Committee, Dr. Mudit Bansal	Approved
Sangini Hospital Ethics Committee, Dr. Urmil Shah	Approved
Shree Institutional Ethics Committee, Dr. Rohit Sanjay Laul	Approved
Shri Ganapati Netralaya Ethics Committee, Dr. Rushikesh Naigaonkar	Approved
Swarnim Ethics Committee, Dr. Parth Rana	Approved
The Institutional Ethics Committee, Shri Sadguru seva Sangh Trust, Dr. Alok Sen	Approved
Unity Hospital Ethics Committee, Dr. Shobhana Mange	Approved
YAKSHIT INDEPENDENT ETHICS COMMITTEE, Dr Abhishek Dixit	Approved
Yakshit Independent Ethics Committee, Dr. Atul Sahu	Approved

Regulatory Clearance Status from DCGI

Status

Approved/Obtained

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: H00-H59\|\|Diseases of the eye and adnexa,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Aflibercept Intravitreal injection	Dose: 2 mg (0.05 mL of 40 mg per mL solution) in a single dose vial, Route of Administration: Intravitreal injection, Duration: 12 weeks (3 doses)
Comparator Agent	Eylea® (aflibercept) Intravitreal injection	Dose: 2 mg (0.05 mL of 40 mg/mL solution) in a single-dose vial/PFS, Route of Administration: Intravitreal injection, Duration: 12 weeks (3 doses)

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1) Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Male or female (assigned at birth, inclusive of all gender identities) gender. 3) Age of greater than or equal to 18 years (completed years) at the time of signing the informed consent. 4) Participant with Type 1 or Type 2 diabetes mellitus who present with central DME involvement defined as retinal thickening with a measurement of 300 um or more involving the 1 mm central subfield by SD-OCT] in the study eye at screening and confirmed by the Central Reading Centre (CRC). Note: If both eyes are eligible, the eye with the worse visual acuity will be selected as a study eye. However, the investigator may select the eye with better visual acuity, based on medical reasons or local ethical requirements. 5) BCVA of 78 to 23 letters, inclusive (20 per 32 to 20 per 320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters at screening and baseline. 6) Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis. 7) Criteria removed as per the protocol Version 2.0. 8) Good health as determined by past medical history, physical examination, vital signs, and laboratory tests at screening. 9) Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: i) Is not a woman of childbearing potential (WOCBP) Appendix 4 OR ii) Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4, during the intervention period and for at least 3 months after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. iii) A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their own use during the recommended period of contraception. iv) A WOCBP must have a negative highly sensitive serum pregnancy test at screening and urine pregnancy test within 24 hours before the first dose of study intervention. v) If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. vi) Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.6. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy. 10) Willing and able to adhere to the lifestyle restrictions specified in this protocol.

ExclusionCriteria

Details

1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or
components or excipients thereof (refer to the locally approved prescribing information of
Eylea), or drug or fluorescein or other allergy that, in the opinion of the investigator,
contraindicates participation in the study.
2) Contraindications to the use of Eylea as per locally approved prescribing information of
Eylea.
3) Had major surgical procedure within 4 weeks before screening, or will not have fully
recovered from surgical procedure, or has surgical procedure planned during the time the
participant is expected to participate in the study. NOTE: Participants with any planned surgical procedure under local anaesthesia only may
participate if they agree to seek prior approval from the investigator and such planned
procedure is not expected to prevent, limit, or confound the protocol-specified assessments as
assessed by the investigator.
4) Central subfield of the study eye affected by fibrosis or geographic atrophy assessed through
colour fundus photography by the CRC at screening.
5) Total area of scarring (involving central subfield) greater than or equal to 50 percentage of the total lesion in the study eye assessed through colour fundus photography by the CRC at screening. Total lesion area is defined as contiguous area of abnormal tissue that will include blood, scars, neovascularization, fibrosis and atrophy.
6) Subretinal haemorrhage in the study eye that involves the centre of the fovea and or the size
of the haemorrhage (involving central subfield) is either greater than 50 percentage of the total area of the lesion or greater than or equal to 1 disc area in size at screening as confirmed by CRC.
7) High-risk proliferative diabetic retinopathy (PDR) in the study eye, using any one of the
following established criteria for high-risk PDR:
i) Any vitreous or pre-retinal haemorrhage
ii) Neovascularization elsewhere greater than or equal to 1 or 2 disc area within an area equivalent to the mydriatic
ETDRS 7 fields or 4 wide fields on CFPs
iii) Neovascularization at disc reater than or equal to 1 or 3 disc area on clinical examination.
8) Prior interventions in the study eye:
i) Prior treatment with verteporfin (photodynamic therapy), External beam radiation
treatment and Transpupillary thermotherapy in the study eye.
ii) Prior any intravitreal injection in the study eye.
iii) Prior macular laser photocoagulation (focal or grid or micropulse) in the study eye at any time
prior to baseline and peripheral laser photocoagulation in the study eye within 3 months
prior to baseline.
iv) Prior vitrectomy in the study eye.
v) Prior Glaucoma filtration surgery in the study eye.
vi) Prior Corneal Transplant in the study eye.
vii) Sub-macular surgery or any surgical intervention for DME in study eye.
viii) Prior ocular surgery (including cataract) within the previous 3 months from baseline in the
study eye.
9) Presence of CNV (confirmed by Central Reading Centre) in either of the 2 eyes due to other
causes (based on Investigator’s discretion) such as AMD, RVO, ocular histoplasmosis, trauma,
multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia.
Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography
(FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT).
Presence of CNV will be evaluated by the Central Reading Centre, whereas the cause for the
same will be assessed by the Investigator.
10) Prior treatment with:
i) Anti-VEGF including Aflibercept, Faricimab, Brolucizumab, Ranibizumab, Bevacizumab
and Pegaptanib (intravitreal or systemic) in either eye.
ii) Intraocular use of corticosteroids in the study eye.
iii) Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within
the 90 days period prior to Baseline.
iv) Use of systemic corticosteroids for 30 or more consecutive days prior to Baseline. Note:
Low stable doses of corticosteroids [defined as less than or equal to 10 mg prednisolone or equivalent dose], inhaled, nasal or dermal steroids are permitted.
11) History or evidence of the following in the study eye at screening and/or baseline visit:
i) Retinal pigment epithelium (RPE) rip per tear involving the macula at Screening or Baseline
in the study eye.
ii) Current vitreous haemorrhage or history of vitreous haemorrhage within 4 weeks prior to
Baseline in the study eye.
iii) Any macular abnormality (including a history of macular hole stage 2 and above) other
than DME at Screening.
iv) Uncontrolled glaucoma in the study eye [defined as intraocular pressure (IOP) greater than or equal to 30 mmHg or a cup to disc ratio greater than or equal to 0.8, despite treatment with antiglaucoma medication] and any such
condition for which the investigator feels may require a glaucoma-filtering surgery while
in the study.
v) For participants who have undergone prior refractive or cataract surgery in the study eye,
the preoperative refractive error in the study eye does not exceed 6 diopters of myopia.
vi) Advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual
field in the study eye at Screening or Baseline.
vii) Aphakia and or absence of the posterior capsule at Screening or Baseline in the study eye.
Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium
Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior
chamber intraocular lens (IOL) implantation.
viii) Rhegmatogenous retinal detachment in the study eye at Screening and or Baseline.
12) Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in
either eye within 4 weeks prior to baseline.
13) Any active intraocular inflammation (grade trace or above), ocular or periocular infections in
the study eye within 4 weeks prior to baseline.
14) History of idiopathic or autoimmune associated uveitis in either eye.
15) Criteria modified as per the protocol Version 2.0:
15.1 Uncontrolled diabetes mellitus as defined by HbA1c greater than or equal to 10 percentage OR fasting blood sugar greater than or equal to 180
mg per dL OR post-prandial blood sugar greater than or equal to 270 mg per dL at screening visit.
16) Uncontrolled blood pressure (defined as systolic greater than 180 mmHg and or diastolic greater than 100 mmHg
while a participant is at rest). If blood pressure is out of range, up to 2 repeated assessments are
permitted no more than 60 minutes apart.
Note: Participants may be re-tested or rescreened after initiation or adjustments of
antihypertensive medications to establish control. If a participant blood pressure is controlled
by antihypertensive medication, the participant should be taking the same medication and
dosage continuously for at least 30 days prior to Day 1.
17) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV
antibody test at screening.
18) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first
dose of investigational intervention.
19) Positive hepatitis C antibody test result at screening or within 3 months prior to starting
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to
prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is
obtained.
20) Participants with a prior or concurrent malignancy whose natural history or treatment has the
potential to interfere with the safety or efficacy assessment of the investigational regimen.
The life span is limited to less than 6 months.
21) Participants with documented cardiac illness or thromboembolic events in the past 6 months
before screening that could lead to a safety risk in the opinion of the Investigator.
22) Past or intended use of any disallowed therapies as noted in Section 6.9, prior to the first dose
of study intervention. [Specific medications listed in Section 6.9 may be allowed.]
23) Received an investigational intervention or used an invasive investigational medical device
within 30 days or 5 half-lives prior to the first dose of study intervention, whichever is longer,
or is currently enrolled in an investigational study.
24) Documented medical history of uncontrolled, clinically significant intercurrent medical
condition(s) for which, in the opinion of the investigator, participation would not be in the
best interest of the participant (e.g., compromise the well-being) or that could prevent, limit,
or confound the protocol-specified assessments.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Double Blind Double Dummy

Primary Outcome

Outcome	TimePoints
To establish clinical equivalence of Aflibercept-Test versus Aflibercept- Reference in participants with DME	The mean change from baseline in BCVA, as assessed by ETDRS letters, at Week 8.

Secondary Outcome

Outcome	TimePoints
To compare the efficacy of Aflibercept-Test and Aflibercept-Reference in participants with DME.	i) The mean change from baseline in Central subfield thickness (CST), as determined by spectral-domain-optical coherence tomography (SD-OCT) up to Week 12. ii) The mean change from baseline in BCVA, as assessed by ETDRS letters up to Week 12. iii) Proportion of participants who gained greater than or equal to 15 letters from Baseline in BCVA, as assessed in change from baseline in ETDRS letters up to Week 12. iv) Proportion of participants avoiding a loss of greater than or equal to 15, greater than or equal to 10, greater than or equal to 5, or greater than 0 letters in BCVA from baseline over time.
To compare immunogenicity of Aflibercept- Test and Aflibercept-Reference in participants with DME.	Incidence of Anti-Drug Antibodies (ADAs) and neutralizing antibodies (nAb) to aflibercept and titer.
To evaluate the ocular and non-ocular safety and tolerability of Aflibercept	i) Incidence and severity of ocular adverse events throughout the study. ii) Incidence and severity of non-ocular adverse events throughout the study.

Target Sample Size

Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

Phase 3

Date of First Enrollment (India)

02/07/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="0"
Months="3"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

To compare the efficacy, safety and immunogenicity of aflibercept intravitreal injection and Eylea (Aflibercept) intravitreal injection in patients with Diabetic Macular Oedema (DME)