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CTRI Number  CTRI/2024/02/063012 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 26/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   A phase I study to evaluate the safety of GBL1204 in patients with neovascular age-related macular degeneration 
Scientific Title of Study   A prospective, multi-centre, open label, single-arm, phase I study to evaluate the safety of GBL1204 in patients with neovascular age-related macular degeneration 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GBL1204/2023/01 Version 1.1 Dated 19.01.2024  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  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinod Kumar   All India Institute of Medical Sciences (AIIMS)  Room No. 272, 2nd Floor,Dr.Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), Ansari Nagar, 110029
New Delhi
DELHI 		 9868420620

Drvinod_agg@yahoo.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 		 7776026323

nilesh.giri@dpu.edu.in 
Dr Satish K  KR Hospital  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 Sourabh Patwardhan  Nandadeep Eye Hospital  Clinical Research Department, Ground Floor, Nandadeep Eye Hospital, Opposite Patidar Bhavan, Madhavnagar Road, 416416
Sangli
MAHARASHTRA 		 9404705777

Patwardhan.sourabh@gmail.com 
Dr Moneesh Saxena   Shri Aurobindo Nethralaya  Near Ramkrishna Care Hospital, Pachpedi Naka, Lalpur, 492001
Raipur
CHHATTISGARH 		 9926829189

moneesh17@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Ethics Committee, Sanjeevani Cancer Hospital  Approved 
Ethics Committee,Dr.D.Y.Patil Vidyapeeth  Approved 
IEC-MMC and RI and Associated Hospital Mysore Medical College and Research Institute  Approved 
IEC-Saishwari Clinic -Hospital for Mental Health  Approved 
Institute Ethics Committee All India Institute of Medical Sciences  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
Modification(s)  
Type  Name  Details 
Intervention  GBL1204   A single injection of 1.25 mg of the study drug is administered intravitreally (0.05 mL of 25 mg/mL solution) in the study eye. 
Comparator Agent  Not Applicable   Not Applicable  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Male or female subjects of age ≥ 50 years.
2.Active primary or recurrent sub-foveal lesions with classic or occult choroidal neovascularization (CNV) secondary to wet AMD in the study eye, as confirmed by fluorescein angiography (FA).
3.Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
4.Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
5.Menopausal females must have experienced their last period at least 12 months prior to study entry to be classified as not of childbearing potential. Women of child-bearing potential and men must be practicing effective contraception implemented during the trial and for the remaining duration of the study

 
 
ExclusionCriteria 
Details  1.Any active or significant ocular disease, ocular disorders, or conditions, such as diabetic retinopathy, retinal vascular occlusion etc. in the study eye other than wet AMD.
2.CNV in either eye due to other causes, such as diabetic retinopathy, ocular histoplasmosis, trauma, or pathologic myopia.
3.History of sub macular surgery or other surgical intervention for AMD, previous intravitreal drug delivery or vitrectomy surgery in the study eye.
4.Intraocular surgery (including cataract surgery) within 2 months in the study eye prior to enrolment.
5.History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study eye.
6.Current vitreous haemorrhage, subretinal haemorrhage that involves the fovea, subfoveal fibrosis or atrophy, active intraocular inflammation, or infection in the study eye.
7.Treatment with verteporfin photodynamic therapy in the study eye within 6 months or in the non-study eye within 1 week prior to enrolment.
8.Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal focal laser photocoagulation in the study eye.
9.Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month prior to screening.
10.Received anti-VEGF treatment for wet AMD within 3 months prior to screening.
11.Uncontrolled glaucoma (defined as intraocular pressure of 25 mmHg or more despite treatment with antiglaucoma medications) or history of glaucoma filtering surgery in the study eye.
12.Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the study period, or that can compromise the visual acuity of the study eye such as amblyopia and anterior ischemic optic neuropathy.
13.Subject with history of idiopathic or autoimmune-associated uveitis in either eye.
14.Subjects with active eye infections such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
15.Subjects with controlled or uncontrolled diabetes mellitus.
16.Subjects receiving anticoagulant therapy.
17.PT and a PTT > 1.5 times of ULN.
18.Subjects test positive for HIV, HBsAg, HCV.
19.Stroke or myocardial infarction within 6 months prior to study drug administration, uncontrolled hypertension (systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥100 mmHg), etc.
20.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) is more than twice the upper limit of normal (ULN), and/or serum creatinine is 1.2 times more than the ULN and is clinically significant in the opinion of the Investigator.
21.Pregnant and lactating women and those who cannot take contraceptive measures.
22.Known allergy to any component of the study intervention or history of allergy to fluorescein (only for subjects who have to undergo FA examination for diagnosis purposes) or any anaesthetics or antimicrobial agents used during the course of the study.
23.Likely candidate for intraocular surgery (including cataract surgery) in the study eye during the clinical trial.
24.Hypersensitivity to study drug or any of the excipients in study medication, or history of allergy to fluorescein.
25.Currently enrolled or participation in any clinical study of an investigational product within previous 3 months.
26.Current signs or symptoms of significant, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease that renders the subject incapable of participating in the study.
27.Any significant poorly controlled illness that would preclude study compliance and follow-up.
28.Current or prior use of any medication known to be toxic to the retina or optic nerve including, but not limited, to chloroquine/ hydrochloroquine, deferoxamine, phenothiazines and ethambutol.
29.History of other disease, active systemic infection, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
30.Any psychological, familial, sociological, geographical, or other condition that would preclude study compliance and follow-up.
31.Any other situation in the opinion of the investigator, the subject is deemed inappropriate to participate in this study.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Type, severity & incidence of ocular adverse events post treatment.  At day 7 
 
Secondary Outcome  
Outcome  TimePoints 
1.Type, severity & incidence of ocular adverse events post treatment.
2.Type, severity & incidence of non-ocular systemic adverse events.
3.Incidence of Serious Adverse Events.
4.Change in BCVA score.  		 1.At day 28
2.At day 7 & day 28
3.Till day 28
4.From baseline to day 28 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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 1 
Date of First Enrollment (India)   15/03/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [Sanjay.Singh@gennova.co.in].

  6. For how long will this data be available start date provided 01-09-2024 and end date provided 31-08-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This clinical trial will be a prospective, multi-center, open label, single-arm, phase I clinical study to evaluate the ocular safety of an intravitreal injection of GBL1204 in patients with neovascular age-related macular degeneration (wet AMD).

In this study, a total of 16 participants with exudative or wet AMD will be enrolled. 

Eligible subjects will be administered a single intravitreal injection of 1.25 mg of the study drug (GBL1204) (0.05 mL of 25 mg/mL solution) in the study eye.

Subjects will be followed up at site till day 28 for safety evaluations.


 
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