A Double Masked, Parallel Group, Randomized, Multicenter, Clinical Study to Compare Efficacy and Safety of Intas Ranibizumab with Lucentis® in Patients with Neovascular (Wet) Age Related Macular Degeneration (AMD).
Department of Ophthalmology,Room No.N/A, Sola, Near Gujarat High Court, S.G Highway, Sola, Ahmedabad, Gujarat 380060, India Ahmadabad
9426541167
deepika1103@yahoo.com
DrKishore Pahuja
Natasha Eye care and Research Centre
Department of Clinical Research,Room No.N/A,Sai Saheb society,Building A, Opp Vasant Avenue, Shiv Sai Lane, Pimpale Saudagar, Pune-411027, Maharashtra, India. Pune MAHARASHTRA Pune
9890086862
kishorepahuja@gmail.com
Dr Sharad Bhomaj
Shanti Saroj Netralay
Department of Clinical Research,Room no.NA,A.N Gaikwad, 901/902, Beside Sundar Nagar, Anand Nursing Home Road, Off Sangli-Miraj Rd, Miraj, Maharashtra, India-416410 Sangli MAHARASHTRA Sangli
9960516364
sharadbhomaj@reddifmail.com
DrHT Venkate Gowda
Adichunchanagiri Hospital & Research Centre
Department of Clinical research,Room No.N/A,B-G, Nagaruru, Nelmangala, Bangalore, Dasanapura,Karnataka 571448 Bangalore
9448945499
drvgmmc@gmail.com
DrMohit Dogra
Advance Eye Centre
Department of Clinical Research,Room No.N/A,PGIMER, Sec-12, Chandigarh Chandigarh
9814108019
mohit_dogra_29@hotmail.com
Dr Gopal Pillai
Amrita Institute of Medical Sciences
Department of Clinical Research,Room No.NA, Ponekkara, P. O, Kochi, Kerala 682041 Kozhikode
9447391266
gopalspillai@gmail.com
DrShamik Prafull Mokadam
Anjani Eye Care Hospital
Department of Clinical Research,Room No.20,Central Bazar Road , Lokmat Square , New Ramdaspeth, Nagpur. Nagpur
7875554968
drshamik@gmail.com
Dr George J Manayath
Aravind Eye Hospital
Department of Clinical Research,Room No.N/A,Aravind Eye Hospital & Post Graduate Institute of Opthalmology Avinashi Road Coimbatore-641014 Coimbatore
04224360400
cbe.retinastudy@aravind.org
Dr Manavi Sindal
Aravind Eye Hospital & Postgraduate Institute of Opthalmology
Department of Clinical Research, Room No. NA, Cuddalore Main road, Thavalakuppam, Pondicherry-605007 Pondicherry
9884081417
manavi@aravind.org
Dr Naresh Babu
Aravind Eye Hospital & Postgraduate Institute of Opthalmology
Department of Clinical Research, Room No. NA, Aravind Eye Hospital and Post Graduate Institute of Opthalmology No. 1 Anna Nagar -Madurai -625020 Madurai
4524356100
cauveryeye@gmail.com
DrRicha Ranjan
Bharti Eye Foundation
Department of Clinical Research,Room no,N/A,Bharti Eye Foundation, 1/3, Block -1, East Patel Nagar-110008 New Delhi
9211722214
foundation.bhartieye@gmail.com
DrLalit Verma
Centre for Sight
Department of Clinical Research,Room No.B – 5/24, Safdarjung Enclave, Opposite, Deer Park, Safdarjung Enclave, New Delhi, Delhi 110029 New Delhi
9810299934
lalitverma@yahoo.com
DrManoj S
Chaitanya eye Hospital & Research Institute
Department of Clinical Research,Room No. N/A,Chaitanya eye Hospital & Research Institute, Kesavadasapuram, Trivandrum, Kerala- 695004 Thiruvananthapuram
4712955500
drmanojsoman@gmail.com
Dr Anup Kumar Shah
Chopda Medicare & Research Centre Pvt. Ltd’s - Magnum Heart Institute
Plot No.3/5, Patil Lane Number 1, opp. Vasant Market, Yashwant Colony, Patil Colony, Laxmi Nagar, Near K. B. H. Vidyalaya, Canada Corner, Nashik, Maharashtra 422005 Nashik
9850501495
dranupshah@gmail.com
DrPrakash VS
Comtrust Eye Hospital Department of Ophthalmology
Department of Clinical Research,Room No,N/A, Mini Bypass Road Puthiyara, Calicut 673004, Kerala, India Kozhikode
04952727942
prakashvresearch@gmail.com
Dr Nilesh V Parekh
Department of ophthalmology, Sir takhtsinhji Hospital
Department of ophthalmology,Room No.N/A, Sir takhtsinhji Hospital, Bhavnagar, Gujarat-364001 Bhavnagar
9428408788
drnvparekh@hotmail.com
Dr Subhendu Kumar Boral
Disha Eye Hospital
Department of Clinical Research, Room No. NA, 88(63A), Ghosh Para road, Barrackpore, Kolkata-700120, West bengal, India Kolkata
9830055015
drsubhendu@yahoo.co.uk
Dr Debdulal Chakraborty
Disha Eye Hospital Sheoraphuli
Department of Clinical Research,Room No. NA,14, Grand Trunk Rd, Sheoraphuli, West Bengal 712223 Hugli
9433059923
devdc.dr@gmail.com
DrSwapnil Pachchigar
Divya Jyoti Trust Tejas eye hospital
Department of Clinical Research,Room No. N/A,Faliya, Opp. Hanuman temple, Mandvi, Dist-Surat Surat
8866337348
swapnilpachchigar@gmail.com
Dr Virendra Agrawal
Dr Virendra Laser Phaco Surgery Centre
Department of Ophthalmology,Room No.N/A, Tonk Phatak, Gandhi Nagar, Tonk Road, Jaipur-302015, Rajasthan, India Jaipur
9314017147
drvirendra@yahoo.com
Dr Lional Raj
Dr. Agarwals Eye Hospital
Department of Clinical Research,Room No.No. 10, South bypass road, Vannarpettai, Tirunelveli Tirunelveli
8754411261
drlionalraj@gmail.com
Dr Maneesh Bapaye
Dr. Bapaye Hospital
Department of Clinical Research,Room No. NA,Old Agra Rd, Opposite Hotel Samrat Behind NDCC Bank, near Old CBS, Nashik, Maharashtra 422001 Nashik
9423176070
maneeshbapaye@gmail.com
Dr Vinod Kumar
Dr. Rajendra Prasad Centre for Opthalmic Sciences
Department of Clinical Research,Room No.N/A,AIIMS Campus Temple, Sri Aurobindo Marg, Ansari Nagar,Ansari Nagar East, New Delhi-110029, India East
9868420620
drvinod_agg@yahoo.com
Dr Amit Basia
Dr.Agarwals Eye Hospital, Panjagutta
Department of Clinical Research,Room No,Dr.Agarwals Eye Hospital, Datla Pride, Metro pillor NO:29 6-3-712/80, near Panjagutta, Punjagutta Officers Colony, Punjagutta, Hyderabad, Telangana 500082 Hyderabad
9582949293
amitbasia@yahoo.com
Dr Palanivel Venkatesan
Dr.Agrawal Eye Hospital
Department of Clinical Research,Room No.No 222, TTK Road, Alawarpet, Chennai - 600018, Tamil Nadu Chennai
9849629312
palvision@yahoo.com
DrRani Sujatha
Dr.B.R Ambedkar Medical College & Hospital
Department of Clinical Research,Room No.48, Indrajit Swamy Layout, Shampur Main Road, Near Ambedkar Medical College, Shampura, Bengaluru, Karnataka 560045 Bangalore
9845747578
drranisujatha@gmail.com
Dr Somesh Aggarwal
Government Eye Hospital
Department of Clinical Research,Room No. NA, M & J Western Regional Institute of Ophthalmology, Asarwa- 380016 Ahmadabad
9427029044
dr.somesh@yahoo.com
DrShalini Mohan
GSVM Medical College
Depatment of Opthalmology ,Room No.N/A,GSVM Medical college,Swaroop Nagar, Kanpur-208002 Kanpur Nagar
9506740966
shalinimohan@gmail.com
Dr Abhishek Anand
Indira Gandhi Institute of Medical Sciences
Department of Clinical Research,Room No. NA,Indira Gandhi Institute of Medical Sciences, Allahabad bank, Bailey Rd, Sheikhpura, Patna, Bihar 800014 Patna
8521861068
ashumishra2287@gmail.com
DrAniruddha Nalgirkar
Kamalnayan Bajaj Hospital
Department of Clinical Research,Room No.N/A,Bajaj Marg, Gut No 43, Beed Bypass Rd, Satara Parisar, Aurangabad, Maharashtra- 431010 Aurangabad
9822861268
nalgirkar@rediffmail.com
Dr Anand Subramanyam
KBHB Eye Hospital
Department of Clinical Research,Room No.NA,58/60, Jehangir Merwanji Road, Parel, Mumbai, Maharashtra 400012 Mumbai
9820800018
kbhb.hospital@gmail.com
Dr Vaishal Pravin Kenia
Kenia Eye Hospital
Department of Clinical Research,Room No.1st floor, Rizvi nagar, S.V. Road, corner of milan subway, santacruz, west mumbai 400054 Mumbai
7506499962
Keniaeye@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
DrAshish Sharma
Lotus Eye Hospital
Department of Clinical Research,Room No.N/A,770 / 12 Avinashi Road, Civil Aerodrome Post, Coimbatore – 641014 Coimbatore
8144973937
drashish79@hotmail.com
Dr Raja Narayanan
LV Prasad Eye Institute
Department of Clinical Research,Room No. NA,Kallam Anji Reddy Campus, LV Prasad Marg, opp. PVR, Park View Enclave, Banjara Hills, Hyderabad-500034, Telangana Hyderabad
9177111975
narayanan@lvpei.org
DrSrinivas M Joshi
M.M Joshi Eye Institute Pvt,Ltd.
Department of Clinical Research,Room no.N/A,M.M Joshi Eye Institute Pvt,Ltd., Gokul Road, Hosur,Hubli-580021 Dharwad
7022910303
mmjoshieyeinstitute@gmail.com
Dr Swapnil Parchand
MGM eye institute, Raipur
Department of Clinical research,Room No.N/A,MGM Eye Institute, 5th Mile, Vidhan Sabha Road, Saddu, Raipur, Chhattisgarh-493111 India Raipur
9159900933
swapnil@mgmeye.org
Dr Thirumalesh M Basavaraj
Narayana Netralaya
Department of Clinical Research, Room No. #258/a, Narayana Netralaya, NH Campus, Hosur Road- 560099 Bangalore
9845928933
thirumaleshmb@narayananetralaya.com
DrNaresh KumarYadav
Narayana Netralaya
Department of Clinical Research,Room no.121/C, Chord Rd, Near Iskcon Temple, 1st R Block, Rajajinagar, Bengaluru, Karnataka 560010 Bangalore
9980872120
vasudha.naresh@gmail.com
DrAditya Kelkar
National Institute of Ophthalmology
Department of Clinical Research,Room No.1187/30, Off Ghole Road, Near, Mahatma Phule Museum, Shivajinagar, Pune, Maharashtra 411005 Pune
9689893887
adityapune4@gmail.com
DrSribhargava Natesh
Nethra Eye Hospital
Department of Clinical Research,Room no.-08,Poojari Layout ,80 Ft Road, Sanjaynagar,RMV ,2nd stage,Banglore-560094 Bangalore
9342880273
sribhargava.natesh@gmail.com
DrParth Rana
Netralaya Super Speciality Eye Hospital
Department of Clinical Research,Room No.N/A,Chimanlal Girdharlal Road, Shanti Sadan Society, Parimal Garden, Ahmedabad Ahmadabad
7999999344
dr.parth.rana@gmail.com
Dr Rupak Biswas
Netralayam - The Superspeciality eye care center
Department of Clinical Research, Room No. NA, SShree Tower II, RAA-36, Raghunathpur, West Bengal, Kolkata 700059 Kolkata
8420211222
rkbstudy@gmail.com
DrBodhraj Dhawan
NKP Salve Institute Of Medical Sciences & Lata Mangeshkar Hospital
Department of Clinical Research,Room no. N/a,NKPSIMS, Opthalmology Department, Digdoh Hills, Hingna Nagpur Nagpur
7798266550
bodhrajdhawan@gmail.com
DrDeepak Bhojwani
Occura Eye Care & Research Center
Department of Clinical Research,Room No. NA, Rajpath Club, Opp. Kensvile Golf Accademy, Bodakdev-380059 Ahmadabad
7069644087
hari.occura@gmail.com
Dr Nitin Prabhudesai
Prabhudesai Eye Clinic
Department of Clinical
Research,Room No. NA,KOTHRUD, Dhanakawadi, Pune Pune
9762007699
ngpmedha@gmail.com
Dr Sharath Hegde
Prasad Netralaya- Speciality Clinic / Hospital
Department of Clinical Research,Room No. NA,AJ Alse Rd, behind Alankar Theatre, Brahmagiri, Udupi-576101, Karnataka, India Udupi
8792882134
prasadnetralayaudupi@yahoo.com
DrPooja Sharma
Pushpanjali Hospital And Research Center
Department of Clinical Research,Room No.N/A,Pushpanjali palace, Delhi Gate,Agra 282002 Agra
8879422282
poojas05491@gmail.com
DrVasumathy Vedantham
Radhatri Nethralaya
Department of Clinical Research,Room No. NA,No.12, Hindi prachara Sabha street, T.nagar, Chennai-600017 Chennai
9442631370
drvasumathy@gmail.com
Dr Ashimkumar Ghosh
Regional Institute of Ophthalmology
Department of Ophthalmology, Room No. NA, Medical College,88 College Street, Kolkata-700073, West Bengal, India Kolkata
8240895240
akghosheye@gmail.com
Dr Anitha S
Regional Institute of Opthalmology
Department of Clinical Research,Room No. NA,Regional Institute of Opthalmology, Red cross road, vanchiyoor P.O, Thiruvananthpuram- 695035, Kerala Thiruvananthapuram
9847022762
dranithab@rediffmail.com
Dr Alok sen
Sadguru Netra Chikitsalaya
Department of Clinical Research,Room No.NA,Sri Sadguru Seva Sangh Trust, Jankikund, District Satna, Chitrakoot, 210204 Satna
7898201605
draloksen@gmail.com
Dr Rajesh
Sanakra Eye Hospital
Department of Clinical Research,Room No. NA,Sankara Eye hospital, Varathur Main Road, Gunthanahalli Gate, Bangalore - 560037, Karnataka Bangalore
9036952706
drragraj@gmail.com
Dr Dhanashree Ratra
Sankara Nethralaya
Department of Clinical research,Room No.No.18, College Road, Numgambakkam,Chennai-600006 Chennai
9940084285
drdad@snmail.org
DrShilpi Narnaware
Sarakshi Netralaya
Department of Clinical Research,Room No,N/A,Plot No.19 Pragati Co-operative Society,Wardha Road, Nagpur, Maharashtra 440025 Nagpur
9823039707
pk52kule@yahoo.com
Dr Shobhna Mange
Shivam Wellness and Eye Hospital Pvt Ltd
Department of Clinical Research,Room No. NA, 1st floor, International Trade Center Building, HG 1-A, Ring Rd, near Radhekrishna hotel, Majura Gate- 395001 Surat
9898155070
shobha_72@yahoo.com
DrTinku Bali Razdhna
Sir Ganga Ram Hospital
Department of Ophthalmology, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060, India New Delhi DELHI New Delhi
01142251412
tinkubali2020@yahoo.com
Dr Manabjyoti Barman
Sri Sankardeva Nethralaya
Department of Clinical Research,Room No.N/A,Sri Sankardeva Nethralaya,96, Basistha Rd, Beltola Tiniali, Saurabh Nagar, Beltola Tiniali, Guwahati Kamrup
9864086770
barmanmj@gmail.com
Dr Jayanta Kuila
Sunayan Advance eye Institute
Department of Clinical Research,Room no.N/A,Station Road, Salgachia, Tanluk, East Madinipur, West Bengal, India-721636 Medinipur
9163686495
jkuila2022@gmail.com
DrBhavin Patel
Swami Vivekanand Netra Mandir
Department of Clinical research,Room No.N/A,Swami Vivekanand Netra Mandir ,Super Speciality Eye Center,4th floor 300-303 shlok bussiness center beside Apple Hospital,Udhana Darwaja , Surat Gujarat-395009 Surat
9727719591
drbhavinj3319@gmail.com
DrMohita Sharma
Tirupati Eye Center
Department of Clinical Research,Room no.C-53,NTPC township C Block ,Sector 33, Noida, Uttar Pradesh-201301 Gautam Buddha Nagar
9560889495
drmohita@tirupatieye.org
Dr Swapnil Bhalekar
Vision Care Center, Superspecialty Eye Hospital
Department of Clinical Research,Room No.NA,Vision Care Center, Superspecialty Eye Hospital, Sushila Park, Shirur, Dist. - Pune Pune
Virtuous Institutional Medical Research Ethics Committee,Dr.Shilpi Narnaware
Approved
Vision Care Centre Super Speciality Eye Hopital,Dr. Swapnil Bhalekar
Approved
Vision Research Foundation,Dr Dhanashree Ratra
Approved
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
Intervention
Intas Ranibizumab 0.5 mg
Dose: 0.5 mg intravitreal injection every 4 weeks; Pharmaceutical form: Single-use vial/PFS of 0.05 mL; Route of administration: Intravitreal injection
Comparator Agent
Lucentis®
Dose: 0.5 mg intravitreal injection every 4 weeks; Pharmaceutical form: Single-use vial/PFS of 0.05 mL; Route of administration: Intravitreal injection
Inclusion Criteria
Age From
50.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1. Male or female participants aged 50 years or more at the time of screening.
2.Written informed consent at Screening must be obtained before any assessment is performed.
3.Willingness and ability to undertake all scheduled visits and assessments.
4.Newly diagnosed, treatment naïve patients with active subfoveal choroid neovascularization (CNV) lesion secondary to neovascular (wet) age-related macular degeneration (AMD) in the study eye at Screening and confirmed by the Central
Reading Center (CRC).
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) and must involve central subfield:
a.The area of CNV must be more than 50% of the total lesion area in the study eye confirmed
by the CRC, and
b.Total lesion area more than 9 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye.
c.All subtypes of nAMD CNV lesions are permissible (i.e., classic CNV, occult CNV,
or with some classic CNV component)
5.Good health as determined by past medical history, physical examination, vital signs,
and laboratory tests at screening.
6. BCVA of 20/40 to 20/200 (more then 73 and less then 34 ETDRS letter score) in the study eye using ETDRS chart at a distance of 4 meters at Screening and Baseline.
7.Fellow eye should not be expected to need any anti-VEGF treatment during the initial 8 weeks period of study participation.
ExclusionCriteria
Details
1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, except for:
a.Women whose partners have been sterilized by vasectomy or other means.
b. Women using a highly effective method of birth control (i.e. one that results in a
less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs); periodic abstinence (e.g. calendar, ovulation, symptothermal, postovulation methods) is not acceptable).
2.Fertile males, defined as all males physiologically capable of conceiving offspring
UNLESS,
a.the participant agrees to comply with two highly effective contraceptive methods comprising a barrier method (condom or occlusive cap plus spermicide) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child for at least three (3) months following the last study drug administration.
3.Pregnant or nursing (lactating) women.
4.Central subfield of the study eye affected by fibrosis or geographic atrophy assessed by
color fundus photography and confirmed by the CRC at Screening.
5.Total area of scarring more than 50% of the total lesion in the study eye at Screening and confirmed by the CRC, in the study eye.
6.Subretinal hemorrhage in the study eye that involves the center of the fovea and/or the
size of the hemorrhage is either more than 50% of the total area of the lesion or more than 1-disc area in size at screening as confirmed by CRC.
7.Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in either eye within 4 weeks prior to Baseline.
8.Any active intraocular inflammation (grade trace or above) in the study eye within 4
weeks prior to Baseline.
9.History of idiopathic or autoimmune associated uveitis in either eye.
10.CNV in either of the two eyes due to causes other than AMD such as DME, RVO,histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia (spherical equivalent of –6 diopters or more negative).
11.Prior interventions in the study eye
a.Prior Treatment with verteporfin, External
beam radiation treatment and Transpupillary thermotherapy in the study eye
b.Prior any intravitreal injection in the study eye.
c.Prior laser photocoagulation in the study eye
d.Prior vitrectomy in the study eye
e.Prior Glaucoma filtration surgery in the study eye
f.Prior Corneal Transplant in the study eye
g.Submacular surgery or any surgical intervention for AMD in study eye
h.Prior ocular surgery (including cataract) within the previous 3 months from baseline in the study eye.
12. Prior treatment with
a. Any prior anti-VEGF including Ranibizumab, Bevacizumab, Aflibercept and Pegaptanib (intravitreal or systemic) in either eye
b.Any prior intraocular use of corticosteroids in the study eye
c. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90 days period prior to Baseline
d.Use of systemic corticosteroids in the past 6 months.Note: Inhaled, nasal or dermal
steroids are permitted
13.Known hypersensitivity to ranibizumab or any of the components of study medication(histidine HCl,trehalose dihydrate or polysorbate) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation or to topical
anesthetics, mydriatic medications.
14.Current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, (tamoxifen,
phenothiazines and ethambutol.
15.History or evidence of the following in the study eye at Screening and/or baseline visit:
a. Retinal pigment epithelium (RPE) rip/tear involving the macula at Screening or Baseline in the study eye
b.Current vitreous hemorrhage or history of vitreous hemorrhage within 4 weeks prior
to Baseline in the study eye
c.Any macular abnormality (including a history of macular hole stage 2 and above)other than AMD at Screening
d.Uncontrolled glaucoma in the study eye(defined as intraocular pressure (IOP) more than 30 mmHg or a cup to disc ratio more than 0.8, despite treatment with antiglaucoma medication)and any such condition for which the investigator feels may require a glaucomafiltering surgery while in the study e.For patients 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
f.Advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye at Screening or Baseline
g.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.
h.Rhegmatogenous retinal detachment in the study eye at Screening or Baseline.
16.Use of other investigational drugs (excluding vitamins, minerals) within 30 days (or as per local regulation) or 5 half-lives prior to Baseline whichever is longer, and for
neovascular AMD (other than vitamin supplements) in the study eye at any time.
17.History of drug or alcohol abuse within the 12 months prior to baseline.
18.Significant illness within two (2) weeks prior to baseline.
19. History of immunodeficiency diseases, including a positive HIV (ELISA or Western
blot) test result. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
20. Presence of uncontrolled systolic blood pressure more than 160 mmHg or uncontrolled diastolic blood pressure less than 100 mmHg based on the average of 3 readings taken with the patient in a resting state (Patients with controlled blood pressure (more than 140/90) with stable antihypertensive treatment regimen will be eligible).
21. Documented medical history of thromboembolic events, stroke, congestive heart failure or recent (within 6 months of screening) myocardial infarction, uncontrolled atrial fibrillation.
22. Documented medical history of bleeding disorders, including platelet disorders,
acquired or hereditary coagulations disorders, and acquired or hereditary vascular
disorders.
23. History of active malignancy except for appropriately treated carcinoma in situ of the
cervix, nonmelanoma skin carcinoma, and prostate cancer with a Gleason score of more than 6 and a stable prostate-specific antigen for more than 12 months.
24. Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that in the judgment of the Investigator,could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition or that limits the potential to gain visual acuity upon treatment with the investigational product (e.g.diabetic retinopathy, cataract, uncontrolled glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc.).
25. History of a medical condition (disease, metabolic dysfunction, physical examination
finding, or clinical laboratory finding) that, in the judgment of the Investigator, would
preclude scheduled study visits, completion of the study, or a safe administration of investigational product, affect interpretation of the results of the study, or renders the
patient at high risk of treatment complications.
Method of Generating Random Sequence
Stratified block randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To establish therapeutic equivalence of Intas Ranibizumab versus Ranibizumab-Ref with respect to the change in best corrected visual acuity (BCVA) from Baseline to Week 8 using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale in adult patients with wet AMD.
Mean change in BCVA in the study eye from baseline to Week 8 using the ETDRS protocol.
Secondary Outcome
Outcome
TimePoints
To compare the efficacy of Intas Ranibizumab versus Ranibizumab-Ref at week 24 and 52.
To compare the efficacy of Intas Ranibizumab with Ranibizumab-Ref based on central foveal thickness, area of choroidal
neovascularization and leakage from choroidal neovascular lesion.
Mean change from baseline in BCVA in the study eye up to 52 weeks using the ETDRS
protocol.
Proportion of patients who gained more than 5,10 and 15 letters in the study eye using ETDRS protocol up to 52 weeks.
Proportion of patients who lost more than 5, 10 and 15 letters in the study eye using ETDRS
protocol up to 52 weeks
Mean change from baseline in the total area of leakage from CNV measured by fluorescein angiography (FA) at Weeks 8 and 52.
Target Sample Size
Total Sample Size="546" Sample Size from India="346"
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 Intas Ranibizumab.
