CTRI/2024/12/077904 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On:
02/05/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Evaluation of GBL1204 in comparison with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (wet AMD).
Scientific Title of Study
A Phase III Prospective, Randomized, Open-labelled, Blinded endpoint (PROBE), Multi-centric, Parallel Group, Non-inferiority Study to compare the Efficacy and Safety of GBL1204 with Ranibizumab in Patients with Wet Age-Related Macular Degeneration (PROMISES Study)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
GBL1204/2024/01, Version 2.0, 18-Sep-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Designation
Affiliation
Address
Phone
Fax
Email
Details of Contact Person Scientific Query
Name
Dr Amit Saraf
Designation
Deputy General Manager
Affiliation
Gennova Biopharmaceuticals Limited
Address
Clinical Research Department, Gennova Vaccine Formulation
Centre and Research Laboratory, BTS-2 Building, Chrysalis
Enclave, Block-2, Plot-2, International Biotech Park, Phase II,
MIDC Hinjawadi
Pune MAHARASHTRA 411057 India
Phone
02035250000
Fax
Email
amit.saraf@gennova.co.in
Details of Contact Person Public Query
Name
Dr Amit Saraf
Designation
Deputy General Manager
Affiliation
Gennova Biopharmaceuticals Limited
Address
Clinical Research Department, Gennova Vaccine Formulation
Centre and Research Laboratory, BTS-2 Building, Chrysalis
Enclave, Block-2, Plot-2, International Biotech Park, Phase II,
MIDC Hinjawadi
Pune MAHARASHTRA 411057 India
Phone
02035250000
Fax
Email
amit.saraf@gennova.co.in
Source of Monetary or Material Support
Gennova Biopharmaceuticals Limited, Pune
Primary Sponsor
Name
Gennova Biopharmaceuticals Limited
Address
Block 1, Plot No. P-1 and P-2, ITBT Park, Phase-II, MIDC,
Hinjawadi, Pune- 411057
Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to Be University
Department of Ophthalmology, SBKS and RC Dhiraj Hospital, Sumandeep Vidyapeeth Deemed to Be University, At & Po. Piparia, Taluka Waghodia, 391760 Vadodara GUJARAT
9879946599
punitsinghdr@yahoo.com
Dr Debdulal Chakraborty
Disha Eye Hospital
Department of Clinical Research 14, Grand Trunk Rd, Sheoraphuli, 712223 Hugli WEST BENGAL
9433059923
devdc.dr@gmail.com
Dr Dinesh Rungta
Disha Eye Hospital Private Limited
88, Kolkata, 63A, Ghoshpara Road Barrackpore, 700120 Kolkata WEST BENGAL
9748303688
drdineshrungta5@gmail.com
Dr Nilesh Balaji Giri
Dr. D.Y. Patil Medical College, Hospital And Research Centre
Clinical Research Unit,
3rd floor, Old Medical
College Building , Dr.D.Y. Patil Medical
College, Hospital and
Research Centre, Sant
Tukaram Nagar, Pimpri,
411018 Pune MAHARASHTRA
5027, Kedar Nath Road Daryaganj , 110002 India New Delhi DELHI
9350666633
drrahulmayor@gmail.com
Dr Gonsai Jigneshgiri Yashvantgiri
Government Eye Hospital, M & J Institute of Ophthalmology
Director office, Manjushri Mill Compound, Asarwa, 380016 Ahmadabad GUJARAT
9824321195
dr_jigneshgosai@hotmail.com
Dr Shalini Mohan
GSVM Medical College
Swaroop Nagar, 208002 Kanpur Nagar UTTAR PRADESH
9506740966
drshalinimohan@gmail.com
Dr Satish K
KR Hospital, Mysore Medical College and Research Institute
Room Number 05, Ground Floor,
Department of Ophthalmology,
K R Hospital,
Mysore Medical College and
Research Institute,
Irwin road, 570001 Mysore KARNATAKA
9886400414
drsatishkeshav@gmail.com
Dr Ashish Sharma
Lotus Eye Hospital and Institute Limited
770/12, Avinashi Road, Civil Aerodrome Post, 641014 Coimbatore TAMIL NADU
8144973937
drashish79@hotmail.com
Dr Raval Vishal Ramesh
LV Prasad Eye Institute
Kallam Anji Reddy Campus L V Prasad Marg, Banjara Hills, Road no.:2, 500034 Hyderabad TELANGANA
8374588011
drvishalraval@lvpei.org
Dr Shashidhar S
Minto Ophthalmic Hospital, RIO BMCRI
Chamrajpet, Tippu Sultan Palace Road, New Tharagupet, 560002 Bangalore KARNATAKA
Ethics Committee, Sanjeevani Cancer Hospital Sanjeevani CBCC USA, Cancer Hospital Front of Jain Mandir Dawada Colony Pachpedi Naka Raipur Chhattishgarh –492001
Harmony Ethical Research Committee Shree Hospital Kavan 70m (Central Avenue), Ambedkar Garden 19th Rd M. S. D. Marg, Chembur, Mumbai Mumbai Mumbai City Maharashtra - 400071 India
Approved
Health1 super speciality hospital EC Health 1 Super Speciality Hospital Block C ,GF To 8 Floor, Shilaj 23/73, On S.P.Ring Road, Near Shilaj Circle, Shilaj. Ahmedabad Gujarat – 380059
Approved
IEC Saishwari Clinic -Hospital For Mental Health Saishwari Clinic -Hospital For Mental Health Yashwant Co Op Housing Society Sangli Road, Miraj, Maharashtra – 416410
Approved
IEC Saishwari Clinic -Hospital For Mental Health Saishwari Clinic -Hospital For Mental Health Yashwant Co Op Housing Society Sangli Road, Miraj, Maharashtra – 416410
Approved
IEC-MMC and RI and Associated Hospital Mysore Medical College and Research Institute, Irwin Road Mysore, Karnataka – 570001
Approved
Institute Ethics Committee All India Institute of Medical Sciences Old OT Block, Room No. 102, AIIMS Hospital Ansari Nagar, New Delhi 110029
Approved
Institutional Ethics Committee , Disha Eye Hospital Pvt. Ltd., 88 (63A), Ghosh Para Road, Barrackpore, Kolkatta, West Bengal - 700120
Approved
Institutional Ethics Committee AIIMS Raipur Room No. 2103, 2nd Floor South Wing Medical College Complex, Gate No. 5 All India Institute of Medical Sciences, Tatibandh, GE Road, Raipur, Chhattisgarh – 492099,
Approved
Institutional Ethics Committee NRS Medical College N.R.S. Medical College and Hospital, 138, A.J.C Bose Road Kolkata, West Bengal – 700014
Approved
Institutional Ethics Committee PBMAs H. V. Desai Eye Hospital S. No. 93 Tarawade Vasti, Mohammdwadi Road Hadapsar Pune, Maharashtra – 411060
Approved
Institutional Ethics Committee Post Graduate Institute of Medical Education and Research Room No. 6006, IEC Office, 6th Floor P N Chuttani Block Chandigarh– 160012
Submittted/Under Review
Institutional Ethics Committee S S Hospital And Research Centre Doctors Colony (Malahi Pakri Chowk) Kankarbagh Patna Patna Bihar - 800020
Approved
Institutional Ethics Committee, AIIMS Bhubaneswar All India Institute of Medical Sciences, BBSR, AIIMS Bhubaneswar Sijua P/O Patrapada Bhubaneswar, Khordha Orissa – 751019
Approved
Institutional Ethics Committee, Ashwin Hospital Ashwin Hospital Number 1 Alamu Nagar Sathy Road Coimbatore Coimbatore Tamil Nadu - 641012
Approved
Institutional Ethics Committee, RIMS, Ranchi Rajendra Institute of Medical Sciences, 4th Floor, Administrative Building Bariatu, Ranchi, Jharkhand – 834009
Approved
Institutional Ethics Committee, SV Sumandeep Vidyapeeth at And Post Pipariya, Vadodara Gujarat– 391760
Approved
Institutional Review Board - Ethics Committee Medical Research Foundation New No.41, Old No.18 College Road Nungambakkam Chennai Tamil Nadu - 600006
Approved
L V Prasad Eye Institute Ethics Committee L V Prasad Eye Institute L V Prasad Marg, Road No 2 Banjara Hills Hyderabad Telangana - 500034
Submittted/Under Review
lnstitutional Ethics Committee Amrita institute of Medical Sciences AIMS-Ponekkara Kochi Edappally Ernakulam Kerala - 682041 lndia
Netrodaya Institutional Ethics Committee Netrodaya The Eye City LLP Arazi No 651 And 652 Near Dafi Toll Plaza, Dafi Varanasi Varanasi Uttar Pradesh - 221008 India
Approved
Shree Institutional Ethics Committee Care Dhadiwal Hospital In Coalitation with Shreeji Health Opp New CBS Trimbak Road Nashik Nashik Maharashtra - 422002
Approved
Sir Ganga Ram Hospital Ethics Committee Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital Old Rajinder Nagar New Delhi - 110060
Submittted/Under Review
SKCC Institutional Ethics Committee , SS Multispecialty Hospital Plot No 13 New Sneh Nagar Near Universal Mansion Wardha Road Nagpur Nagpur Maharashtra - 440015
Approved
Supe Hospital Ethics Committee Supe Heart Diabetes Hospital And Research Centre Opp. Adharashram, Gharpure Ghat Near Rungtha School, Ashok Stambha Nashik Nashik Maharashtra - 422002 India
Approved
The Institutional Ethics Committee B.J Medical College & Civil Hospital, Ahmedabad, Gujrat – 380016
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,
Intervention / Comparator Agent
Type
Name
Details
Intervention
GBL1204
Inj. GBL1204, at a dose of 1.25 mg in 0.05 mL will be administered Intravitreally once every 4 weeks in the study eye until week 12.
The total study duration for each subject will be approximately 18 weeks, including a screening period of up to 10 days, a 12-week treatment period, and a 1-month follow-up period (week 16).
Comparator Agent
Ranibizumab (Accentrix®, Manufactured by Novartis)
Inj. ranibizumab, at a dose of 0.5 mg (0.05 mL) will be administered Intravitreally once every 4 weeks in the study eye until week 12. The total study duration for each subject will be approximately 18 weeks, including a screening period of up to 10 days, a 12-week treatment period, and a 1-month follow-up period (week 16).
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Adult male or female subjects of age equal to or more than 50 years including non-diabetics or subjects with controlled diabetes with prescribed medication who are capable of understanding and giving written informed consent
2.Subjects with a diagnosis of wet AMD confirmed by fluorescein angiography showing the presence of active subfoveal choroidal neovascularization CNV This includes,
a.newly diagnosed active CNV lesion or
b.previously untreated active CNV lesion or
c.subjects with prior treatment of the active CNV lesion at least three months before the enrolment
Active CNV is defined as any leakage detected on FA
3.Total lesion area less than or equal to 12.0 Disc Areas DA in size in the study eye
4.BCVA between 20/320 to 20/40 Snellen equivalent both value inclusive in the study eye before pupil dilation assessed using the ETDRS visual acuity charts
5.Women of non-childbearing potential i e postmenopausal for at least 12 months prior to trial entry, or surgically sterile OR if of childbearing potential a pregnancy test with a negative result must be obtained prior to the first treatment Women of childbearing potential must practice effective contraception during the trial and for at least 60 days following the last dose of the study injection
6.No known contraindication to intravitreal injection of GBL1204 or ranibizumab
7.Willing and able to undertake all scheduled visits and assessments
ExclusionCriteria
Details
1.Subjects with the presence of other significant ocular disorders in the study eye affecting visual acuity, such as:Sub-retinal hemorrhage covering more than 50% of the total lesion area involving the center of the fovea as assessed by FA, scar, fibrosis, or atrophy, involving the center of the fovea, making up more than 50 percent of the total lesion as assessed by FA, retinal pigment epithelial tear involving the macula, presence of a macular hole at any stage, uncontrolled glaucoma (intraocular pressure exceeding 25 mmHg despite treatment) or any other retinal or macular abnormality (other than AMD) that could affect central vision or the efficacy assessments in the study eye.
2.The presence of CNV in the study eye due to other causes, such as ocular histoplasmosis, trauma, angioid streaks, choroidal rupture, pathologic myopia (spherical equivalent of -8.0 diopters or more, or axial length of 25 mm or more), or multifocal choroiditis.
3.Subjects who, in the opinion of the principal investigator (PI), may require medical or surgical intervention within 4 to 5 months of study period, or for whom the decision to prevent surgery or treatment would lead to a loss of best corrected visual acuity during the study period.
4.Subjects, who are unable to be photographed to document CNV, due to known allergy to fluorescein dye, lack of venous access, or cataracts obscuring the CNV.
5.Subject with dense corneal and lens opacities, obstructing the view of central retina.
6.Known hypersensitivity to the components of the study medication (bevacizumab or ranibizumab).
7.Previous treatment with verteporfin PDT, Macugen, ranibizumab, intravitreal Avastin®, thermal laser, external beam radiation, intravitreal steroids, or other AMD therapy in the study eye (except for extrafoveal laser photocoagulation) as well as the contralateral non-study eye within past 3 months before enrolment in the study.
8.Laser photocoagulation in the study eye within 1 month prior to enrolment in the study.
9.Concurrent or any prior use of systemic anti-vascular endothelial growth factor (VEGF) agents.
10.Concurrent treatment with an investigational drug or any medical device in the either eye or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational drug or device study(ies) prior to enrolment.
11.History or clinical evidence of diabetic retinopathy, diabetic macular edema (DME), or any other vascular disease affecting the retina, other than AMD, in either eye.
12.History of vitrectomy, any vitreous hemorrhage, rhegmatogenous retinal detachment, or macular hole in the study eye.
13.History of submacular surgery or other surgical intervention for AMD in the study eye.
14.Active intraocular inflammation including scleritis or active or suspected ocular or periocular infection in either eye (including infectious conjunctivitis, keratitis, scleritis, uveitis, or endophthalmitis), within 2 weeks prior to randomization.
15.History of any intraocular or periocular surgery (including cataract surgery) in the study eye within 2 months prior to enrolment in the study.
16.Having corneal transplant in the study eye.
17.Presence or history of scleromalacia in either eye.
18.For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye cannot exceed 8 diopters of myopia.
19.Subjects who used coumarin derivatives at the time of inclusion.
20.Subjects with immunocompromised status including seropositivity for hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or any other serious uncontrolled concomitant immunodeficiency.
21.Subjects with a history of clinically significant cerebrovascular accident or myocardial infarction in the past 6 months prior to enrollment.
22.Subjects with uncontrolled hypertension (blood pressure exceeding 160/100 mmHg) and uncontrolled diabetes (HbA1c more than 8 percent).
23.Subjects with a history or presence of concurrent systemic diseases or metabolic dysfunctions or abnormal physical examination or clinical laboratory finding that raises reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for treatment complications based on the Principal Investigator’s discretion such as:
cardiovascular disease, uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g., optic neuropathy), metabolic, pulmonary, or autoimmune disease based on previous history and relevant reports of clinical examination, laboratory tests, or electrocardiogram, etc.
24.Subjects with a history of recurrent significant infections or bacterial infections or subjects undergoing treatment for active systemic infection.
25.Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up.
26.Previous participation in any other trial within the last 3 months prior to enrolment in this trial
27.The subject is not suitable to participate in the study at the discretion of the Principal Investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Mean change in best corrected visual acuity (BCVA) in subjects in both groups.
Baseline to Week 16
Secondary Outcome
Outcome
TimePoints
Efficacy
Proportion of subjects who gained 15 letters or more on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Proportion of subjects who lost fewer than 15 letters on the ETDRS chart.
Mean change in central macular thickness as assessed by optical coherence tomography (OCT) in the study eye.
Exploratory
Change in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) total score.
Proportion of patients with anti-drug antibodies (ADAs) againts GBL1204 & ranibizumab.
Efficacy
Baseline to Week 16
Safety
Baseline to Week 16
Exploratory
Baseline to Week 16
Target Sample Size
Total Sample Size="308" Sample Size from India="308" 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)
22/12/2024
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="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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
This is a prospective, randomized, open-labelled, blinded endpoint (PROBE), multi-centric, parallel-group, two-arm, interventional, non-inferiority study designed to compare efficacy and safety of GBL1204 with ranibizumab. The study will enroll 308 adult subjects (age equal to or more than 50 years) diagnosed with wet AMD (154 per treatment arm), confirmed by Fluorescein angiography. The total study duration for each subject will be approximately 18 weeks, including a screening period of up to 10 days, a 12-week treatment period, and a 1-month follow-up period (week 16).