Clinical trial to compare effects and safety of Lupins Ranibizumab with Lucentis® in Patients with Age-Related loss of central vision.
Scientific Title of Study
A Prospective, Randomized, Parallel Group, Double Blind, Multicenter Study to Compare the Efficacy, Safety & Immunogenicity of Lupin’s Ranibizumab with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration
The Ethics Committee of the Eye Foundation, Coimbatore
Approved
The Institutional Ethics Committee B J Medical College and Civil Hospital Ahmedabad
Approved
Yash Societys Sujata Birla Hospital Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
Degeneration of macula and posterior pole
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Lucentis®
Lucentis® supplied as single-use, 2-cc glass vial containing 2.3 mg of ranibizumab in 0.23 mL solution designed to deliver 0.05 mL of 10 mg/mL ranibizumab. Dose of 0.5 mg.Intravitreal injection in the study eye of patients Total three injections per patient; Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Intervention
Lupin’s Ranibizumab
Lupin’s Ranibizumab supplied as single-use, 2-cc glass vial containing 2.3 mg of ranibizumab in 0.23 mL solution designed to deliver 0.05 mL of 10 mg/mL ranibizumab. Dose of 0.5 mg. Intravitreal injection in the study eye of patients. Total three injections per patient; Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Ambulatory male or female participants with age ≥ 50 years at the time of screening who are capable of understanding and giving written informed consent.
2.Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal centre secondary to age-related macular degeneration in any one of the eye. (If both eyes are affected and eligible patient and study ophthalmologist will select one eye for study purpose).
3.Best corrected visual acuity in the study eye using ETDRS testing between 20/ 40 and 20/ 320 (Snellen equivalent) both inclusive before pupil dilation.
4.Females who are of non-child bearing potential (surgically sterile or menopausal) OR if of child bearing potential using effective birth control and non-pregnant & non-lactating.
ExclusionCriteria
Details
Patients who meet any of the following criteria should be disqualified from entering the study:
1. Known hypersensitivity to ranibizumab or any of the components of study medication.
2. Allergy to fluorescein dye.
3. Patients with coexisting CNV lesions secondary to AMD in the non-study eye that would require simultaneous treatment with anti-VEGF therapies during the study period.
Ocular Conditions of the study eye:
4. Any other pathology involving the CNV lesion like retrofoveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug.
5. Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye.
6. Aphakia or absence of the posterior capsule in the study eye.
7. Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment.
8. H/o serious complications following surgery in the study eye within 1 year prior to randomization.
Concomitant Medications/ Treatments & Procedures:
9. Previous treatment with intravenous Bevacizumab (Avastin®), or intravitreal Ranibizumab (Lucentis®), Bevacizumab (Avastin®), Aflibercept (Eylea®), Pegaptanib (Macugen®) in either of the eyes.
10. Previous external beam radiation or subfoveal focal laser photocoagulation/ thermal laser or transpupillary thermotherapy in the study eye within 5 years prior to randomization.
11. Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization.
12. Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or intravitreal or peribulbar steroid in the study eye within past 3 months.
13. Concurrent use of systemic anti-VEGF agents.
14. History of vitrectomy, submacular surgery or other surgical intervention for AMD, corneal transplant or any device implantation in the study eye.
15. Intraocular surgery (including cataract surgery) in the study eye within 2 months prior to randomization.
16. Concurrent treatment with an investigational drug or device in the non-study eye.
17. Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment.
Other Ocular Conditions:
18. CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to ranibizumab.
19. Active or ongoing ocular infection (e.g. infectious conjunctivitis, keratitis, scleritis, or endophthalmitis) or severe inflammation in either of the eyes.
20. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 month study period or that could contribute to a loss (of at least 2 Snellen equivalent lines) of best corrected visual acuity over the 3 months study period (e.g. diabetic retinopathy, progressive retinal disease or retinal pathology, cataract, glaucoma, uveitis, previous corneal transplant, the refractive error more than -8 diopters of myopia etc.). The decision regarding exclusion is to be based on the opinion of the investigator.
General Conditions:
21. Patients with seropositivity for hepatitis B, hepatitis C, HIV antibody, syphilis tests or any immunodeficiency and/ or immunosuppressive disease or active systemic infection.
22. History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/ surgical intervention during study period that might affect interpretation of the results or contraindicates the use of ranibizumab or render the subject at high risk for treatment complications based on the Investigator’s judgment such as:
• Cardiovascular disease (e.g. stroke, myocardial infarction), uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g. optic neuropathy), metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous history and relevant reports of clinical examination, laboratory tests, or ECG etc.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients losing fewer than 15 letters (approximately 3 lines) from baseline Best Corrected Visual Acuity (BCVA) in the study eye at the end of 3 months, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
This is a randomized, comparative, parallel group, two arm, double blind, multi-centerPhase 3 clinical study. The objective of the study is to compare the efficacy, safety and immunogenicity of Lupin’s Ranibizumab to that of Lucentis® in patients with neovascular age-related macular degeneration.
Results:
This study has been completed. The
results of this study showed that Lupin’s ranibizumab demonstrates therapeutic
equivalence to Lucentis in terms of changes in best corrected visual acuity
(BCVA) measured in terms of proportion of patients losing fewer than 15 letters
from baseline as well as mean change in BCVA from baseline in patients with
neovascular age-related macular degeneration. Furthermore, Lupin’s Ranibizumab
demonstrated comparable safety and immunogenicity profile. Lupin’s Ranibizumab
has received marketing authorization on 02 November 2021 by CDSCO
CTRI Number
CTRI/2019/09/021456 [Registered on: 30/09/2019] Trial Registered Prospectively
Last Modified On:
23/06/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify) [Biosimilar ]
Study Design
Randomized, Parallel Group, Active Controlled Trial
Clinical Study of Ranibizumab Biosimilar in Patients with Wet AMD (Age-related macular degeneration)
Scientific Title of Study
A Randomized, Phase 3, Double-masked, Parallel-group, Multicenter Study to Compare Efficacy and Safety of QL1205 Versus Lucentis® in Subjects With Neovascular Age-related Macular Degeneration
Secondary IDs if Any
Secondary ID
Registry
2018-004486-13
EudraCT
QL1205-002 Version 2.0 Dated 21Dec2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Prabhati Mukherji
Address
Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III,
Gurgaon HARYANA 122001 India
Phone
01244642592
Fax
Email
prabhati.mukherji@syneoshealth.com
Details Contact Person Scientific Query
Name
Dr Prabhati Mukherji
Address
Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III,
HARYANA 122001 India
Phone
01244642592
Fax
Email
prabhati.mukherji@syneoshealth.com
Details Contact Person Public Query
Name
Dr Prabhati Mukherji
Address
Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III,
HARYANA 122001 India
Phone
01244642592
Fax
Email
prabhati.mukherji@syneoshealth.com
Source of Monetary or Material Support
Qilu Pharmaceutical Co, Ltd., 243 Gong Ye Bei Road, Jinan, Shandong 250100, China
Primary Sponsor
Name
Qilu Pharmaceutical Co Ltd
Address
243 Gong Ye Bei Road, Jinan, Shandong 250100, China
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
Kendle India Pvt Ltd
Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III, Gurugram-122001, Haryana, India
Countries of Recruitment
Bulgaria China Czech Republic Hungary India Poland Romania Russian Federation Slovakia Spain Ukraine
Acharya Vinoba Bhave Rural Hospital A Constituent Unit of Datta Meghe Institute of Medical Science
Department of Ophthalmology, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra 442001, India Wardha
9372910079
drsachin391977@gmail.com
Dr Sundaram Natarajan
Aditya Jyot Eye Hospital Pvt. Ltd.
Department of Ophthalmology, Plot No. 153, Road No. 9, Major Parmeshwaran Road,
Opp S.I.W.S. College Gate No. 3,, Wadala, Mumbai, 400031, Maharashtra, India
Mumbai
9920241419
prof.drsn@adityajyoteyehospital.org
Dr Vishali Gupta
Advanced Eye Centre PGIMER
Department of Ophthalmology, Sector 12, Chandigarh, 160012, India Chandigarh
9417565506
vishalisara@gmail.com
Dr Ajay Kartik Ambade
Ambade Eye Hospital, Nagpur
Department of Ophthalmology,1st Floor, Kamla Tower Kamptee Road Indora Chowk, Near Jaswant Inox, New Indora, Nagpur, Maharashtra 440017, India Nagpur
0712-2631193
dr_ajayambade@rediffmail.com
Dr Naresh K Babu
Aravind Eye Hospital
Department of Ophthalmology, 1, Anna Nagar, Madurai - 625 020, Tamil Nadu, India Madurai
9443490829
cauveryeye@gmail.com
Dr Alay Banker
Bankers Retina Clinic and Laser Centre
Department of Ophthalmology, 1/B, Surbhi Rd, Sarvottam Nagar Society, Navrangpura, Ahmedabad, Gujarat 380014, India Ahmadabad
9825024655
alay.banker@gmail.com
Dr Prakash VS
Comtrust Eye Hospital
Department of Ophthalmology, Mini Bypass Road Puthiyara, Calicut 673004, Kerala, India Kozhikode
0495-2727942
prakashvresearch@gmail.com
Dr Aratee Palsule
Deenanath Mangeshkar Hospital
Department of Ophthalmology, Near, Mhatre Bridge, Vakil Nagar, Erandwane, Pune, Maharashtra 411004, India Pune
9822300508
palsule.artee@gmail.com
Dr Soumen Mondal
Disha Eye Hospitals Pvt. Ltd.
Department of Ophthalmology, 88 (63A) Ghosh Para Road, Barrackpore,
Kolkata - 700120, West Bengal, India
Kolkata
033-66360000
hisoumenm@yahoo.co.in
Dr Rahul Mayor
Dr Shroff’s Charity Eye Hospital
Department of Ophthalmology, 5027, Kedarnath Road, Daryaganj, New Delhi-110002, India New Delhi
9350666633
drrahulmayor@gmail.com
Dr Arti Elhence
Dr Subodh Agarwal Memorial (SAM) Eye Hospital
Department of Ophthalmology, Rana Pratap Marg, Near National PG College Ground, Hazratganj, Lucknow 226001, Uttar Pradesh, India Lucknow
9956035195
sameyelko@gmail.com
Dr Virendra Agrawal
Dr Virendra Laser Phaco Surgery Centre
Department of Ophthalmology, Tonk Phatak, Gandhi Nagar, Tonk Road, Jaipur-302015, Rajasthan, India Jaipur
9314017147
drvirendra@yahoo.com
Dr Lional Raj
Dr. Agarwal’s Eye Hospital
Department of Ophthalmology, No. 10, S Bypass Road,Vannarpet, Vannarpettai,Tirunelveli-627003, Tamil Nadu, India Tirunelveli
8754411261
drlionalraj@dragarwal.com
Dr Deepika Singhal
GMERS Medical College and Civil Hospital
Department of Ophthalmology, Sola, Near Gujarat High Court, S.G Highway, Sola, Ahmedabad, Gujarat 380060, India Ahmadabad
9426541167
deepika1103@yahoo.com
Dr Perwez Khan
GSVM Medical College
Department of Ophthalmology, Swaroop Nagar, Kanpur, Uttar Pradesh 208002, India Kanpur Nagar
0705-2515253
drperwezkhan.research@gmail.com
Dr Premnath Raman
JSS Hospital
Department of Ophthalmology, MG Road, Near Agrahara Circle, Ramachandra Agrahara, Mysuru- 570004, Karnataka, India Mysore
9880539053
drramanaol@gmail.com
Dr Sanjiv Kumar Gupta
King George Medical University
Department of Ophthalmology, Shah Mina Rd, Chowk, Lucknow-226003, Uttar Pradesh, India Lucknow
9532998211
sanjiv204@gmail.com
Dr Chairmaine Bridgette Solomon
Kozhikode Medical College (Government Medical College)
Department of Ophthalmology, 17 Medical College Road Medical College Junction, Near Police Station, Kozhikode, Kerala 673008, India Kozhikode
9747154907
charmainebridsolomon@gmail.com
Dr Bhavik Panchal
L V Prasad Eye Institute
Department of Ophthalmology, Hanumanthavaka Junction, Gmr Varalakshmi Campus 11-113/1,Visakhapatnam-530040, Andhra Pradesh, India Visakhapatnam
7416434031
bhavik@lvpei.org
Dr Divya Balakrishnan
L V Prasad Eye Institute
Department of Retina, Kallam Anji Reddy Campus L.V. Prasad Marg Banjara Hills, Hyderabad 500034, Telangana, India Hyderabad
040-30612123
divya@lvpei.org
Dr Umesh Chandra Behera
LV Prasad Eye Institute
Department of Ophthalmology, Mithu Tulsi Chanrai Campus, Patia Road, Bhubaneswar-751024, Odisha, India Khordha
9853011697
umesh@lvpei.org
Dr Sudhir Garg
Maharaja Agrasen Hospital
Department of Ophthalmology, Metro Station, Near, Jain Muni Guru Ramkrishan Marg, Block C, Shivaji Park, Punjabi Bagh, Delhi, 110026, India West
Department of Ophthalmology, 121/C, Chord Road, 1st R Block, Rajaji Nagar, Bangalore, Karnataka 560010, India Bangalore
08066121300
drsantoshgk@gmail.com
Dr Kishor Pahuja
Natasha Eye care and Research Centre
Sai Saheb society,Building A, Opp Vasant Avenue, Shiv Sai Lane, Pimpale Saudagar, Pune-411027, Maharashtra, India.
Pune
9890086862
kishorepahuja@gmail.com
Dr Sribharagava Natesh
Nethra Eye Hospital
Department of Ophthalmology, No. 8, Poojari Layout, 80 ft.Road, Sanjayanagar, Bengaluru, Karnataka 560094, India Bangalore
9342880273
sribhargava.natesh@gmail.com
Dr Bodhraj Dhawan
NKP Salve Institute of Medical Sciences & Research Centre & Lata Mangeshkar Hospital
Department of Ophthalmology, Digdoh Hills, Hingna Road, Nagpur – 440019, Maharashtra, India Nagpur
7798266550
bodhrajdhawan@gmail.com
Dr Sucheta Kulkarni
PBMAs, H.V. Desai Eye Hospital
Department of Medical Retina, S. No. 93, Tarawade Vasti, Mohmmadwadi Road, Hadapsar, Pune, Maharashtra- 411060, India Pune
0202-6970043
drsucheta.kulkarni@gmail.com
Dr Nitin Prabhudesai
Prabhudesai Eye Clinic
Department of Ophthalmology, 14, Saket Society, Opp. Siddharth Palace Hall, Near Karishma Society and Joshi Railway Museum, Kothrud , Pune, Maharashtra 411038,India
Pune
9762007699
drnprabhudesai@gmail.com
Dr Deepak Bhojwani
Raghudeep Eye Hospital
Department of Ophthalmology, Near Shreeji Complex, Gurukul Road, Memnagar, Ahmedabad, Gujarat 380052, India Ahmadabad
9727490909
bhojwani.deepak1986@gmail.com
Dr Bibhuti Sinha
Regional Institute of Ophthalmology
OPD Block, First Floor, Indra Gandhi Institute of Medical Sciences, Sheikhpura, Patna-800014, Bihar, India Patna
8521861068
bibhuti13@gmail.com
Dr Krishnapada Baidya
Regional Institute of Ophthalmology
Department of Ophthalmology, Medical College and Hospital, 88 College Street, Kolkata-700073, West Bengal, India Kolkata
9830292615
drkpbaidya@gmail.com
Dr Rohan Chauhan
Rising Retina Clinic
Department of Ophthalmology, 312-313, ISCON, Centre, Shivranjini Cross Roads, Satellite, Ahmedabad-380015, Gujarat, India Ahmadabad
7926925232
rohan_28782@yahoo.co.in
Dr Kumudni Sharma
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Department of Ophthalmology, Raebareli Rd, Haibat Mau Mawaiya, Lucknow, Uttar Pradesh 226014, India Lucknow
8004904441
kumudsgpgi@gmail.com
Dr CK Minija
Sankara Eye Hospital
Department of Ophthalmology, Arthur Rd, Gate, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru, Karnataka 560037, India Bangalore
9480587018
minija_ck@yahoo.co.in
Dr Shilpi Narnaware
Sarakshi Netralaya
Plot No 19, Pragati Cooperative Society, Nagpur 440025, Maharashtra, India Nagpur
9923522016
Shilpi.Narnaware@gmail.com
Dr Sharad Bhomaj
Shanti Saroj Netralay
A.N Gaikwad, 901/902, Beside Sundar Nagar, Anand Nursing Home Road, Off Sangli-Miraj Rd, Miraj, Maharashtra, India-416410 Sangli
9960516364
sharadbhomaj@reddifmail.com
Dr Shobhana Mange
Shivam Retina Clinic and Eye Hospital
HG1-A, ITC Building, Majura Gate, Ring Road, Surat-395001 Surat
7405698000
drshobhanamange@gmail.com
Dr Tinku Bali Razdan
Sir Ganga Ram Hospital
Department of Ophthalmology, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060, India New Delhi
011-42251412
tinkubali2020@yahoo.com
Dr Vishal Agrawal
SMS Medical College and Hospital
Department of Ophthalmology, Charak Bhawan,SMS Medical College and Hospital , JLN Marg, Jaipur - 302001, Rajasthan, India. Jaipur
9024472330
drvishalsms@gmail.com
Dr Aniruddha Maiti
Susrut eye foundation and Research Centre
Department of Ophthalmology, HB-36/A/1, HB Block, Sector III, Salt Lake City, Kolkata, West Bengal -700106, India Kolkata
9836552140
write2maiti@gmail.com
Dr Saroj Sahdev
TN Medical College and BYL Nair Hospital
Department of Ophthalmology, RTO Colony, Mumbai Central, Mumbai, Maharashtra 400008, India Mumbai
022-23027661
sisahdev@hotmail.com
Dr Ezhil Vendhan Kaliamamani
Vinayaka Missions Kirupananda Variyar Medical College
Department of Ophthalmology, NH 47, Sankari Main Rd, Chinna Seeragapadi, Salem, Tamil Nadu 636308, India Salem
The recommended dose for Lucentis® is 0.5 mg (0.05 mL of 10 mg/mL solution) given as a single IVT injection every 4 weeks over a treatment period of 48 weeks. Total 13 Injections.
Intervention
QL1205-Qilu ranibizumab biosimilar
The recommended dose for QL1205 is 0.5 mg (0.05 mL of 10 mg/mL solution) given as a single IVT injection every 4 weeks over a treatment period of 48 weeks. Total 13 Injections.
1. Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator
2. Age ≥50 years at Screening
3. Males, or females of nonchildbearing potential (eg, permanently sterilized, postmenopausal [defined as 12 months with no menses without an alternative medical cause prior to Screening])
4. Newly diagnosed, treatment-naive, active subfoveal CNV lesion secondary to AMD in the study eye. Active CNV means presence of leakage as evidenced by fluorescein angiography (FA) and intra- or sub-retinal fluid as evidenced by optical coherence tomography (OCT) that is confirmed by central reading center during Screening (before randomization)
5. Total lesion area ≤9.0 disc areas in size (including blood, scars, and neovascularization) as assessed by FA in the study eye and confirmed by the central reading center before randomization
6. The area of CNV must be ≥50% of the total lesion area in the study eye confirmed by the central reading center before randomization
7. Best corrected visual acuity of 20/40 to 20/200 in the study eye using ETDRS chart (≤ 73 and ≥ 34 ETDRS letters) at Screening and at Day 1 before randomization.
8. Fellow eye should not be expected to need any anti-vascular endothelial growth factor (VEGF) treatment for the duration of study participation
9. Written informed consent form (ICF) obtained before any study-related procedures or performed.
10. Male subjects must be willing to completely abstain or agree to use an appropriate method of contraception from the time of signing ICF and for the duration of study participation through 3 months after the last dose of study drug.
ExclusionCriteria
Details
1. Previous ocular treatment/surgery for wAMD in either eye
2. Previous intravitreal treatment/vitreal surgery in either eye
3. Any previous intravitreal anti-VEGF treatment (eg, bevacizumab, aflibercept, ranibizumab) in either eye
4. Any previous systemic anti-VEGF treatment
5. Sub- or intraretinal hemorrhage involving the fovea in the study eye of 50% or more of the total lesion area assessed by FA and confirmed by central reading center (Before Randomization)
6. Subfoveal fibrosis or atrophy in the study eye assessed by FA and confirmed by central reading center (before randomization)
7. Scarring exceeding 50% of total lesion size in the study eye and confirmed by the central reading center (before randomization)
8. Choroidal neovascularization in either eye due to nonAMD causes assessed by FA and confirmed by central reading center (before randomization)
9. Retinal pigment epithelial tear involving the macula in the study eye as assessed by FA and confirmed by central reading center (before randomization)
10. Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity
11. Other intraocular surgery (including cataract surgery) or periocular surgery in the study eye within 3 months prior to randomization, except for eyelid surgery within 30 days prior to randomization
12. Corneal transplant in the study eye
13. Active or recent (within 28 days prior to randomization) intraocular, extraocular and periocular inflammation or infection in either eye, including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
14. Current vitreous hemorrhage in the study eye
15. History of retinal detachment in the study eye
16. History of macular hole in the study eye
17. History of idiopathic or autoimmune-associated uveitis in either eye
18. Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a Yttrium Aluminium Garnet posterior capsulotomy in association with prior posterior chamber intraocular lens implantation
19. Presence of advanced glaucoma or optic neuropathy that involves or threaten the central visual field in the study eye
20. History of glaucoma filtering surgery in the study eye
21. Uncontrolled ocular hypertension in the study eye, defined as intraocular pressure ≥ 25 mm Hg despite treatment with anti-glaucoma medication
22. Spherical equivalent of the refractive error in the study eye demonstrating more than 8 diopters of myopia
23. Contraindication for Lucentis® (hypersensitivity to ranibizumab or to any of the excipients, active or suspected ocular or periocular infection, or active severe intraocular inflammation), or known allergic reactions to any ingredients of QL1205
24. Current treatment for active systemic infection
25. Subjects with known history ofseropositivity for hepatitis B, hepatitis C antibody, HIV antibody, syphilis tests, or any immunodeficiency and/or immunosuppressive disease or active systemic infection. Seropositivity for hepatitis B is defined as (1) positive for hepatitis B surface antigen, and (2) positive for hepatitis B virus DNA
26. Reasonable suspicion of a disease or condition that that might render the subject at high risk of treatment complications or affect interpretation of the study results (as judged by the investigator), such as uncontrolled hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure
27. Participation in another clinical trial within the previous 3 months or any previous participation in a clinical trial of anti-angiogenic drugs with receipt of previous study drug within 3 months the ICF for this study
28. Topical ocular corticosteroids administrated for ≥ 30 consecutive days in the study eye within 90 days prior to randomization
29. Any systemic treatment or therapy (including prescribed herbal medication) to treat neovascular AMD within 30 days prior to randomization, and such treatment or therapy will not be allowed during the study period. However, dietary supplements, vitamins, or mineral will be allowed
30. PK subgroup only: contraindication for additional blood sampling (as judged by the investigator)
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
This is a Phase 3, multicenter, randomized, double-masked (double-blinded), randomized, parallel-group study in subjects with wAMD. Subjects will be randomized 1:1 to receive Lucentis® or QL1205.
Subjects in a PK subgroup will provide blood samples for measurement of serum ranibizumab immediately before the first dose of investigational product (QL1205) or reference product (Lucentis®) and 22 hours after the first dose (Day1) and the sixth dose (Week 20) at expected time to maximum serum concentration (0.9 days).
