CTRI/2021/10/037451 [Registered on: 21/10/2021] Trial Registered Prospectively
Last Modified On:
20/11/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study
A clinical study to compare the safety and effectiveness of study drug OPT-302 in combination with ranibizumab, compared with ranibizumab alone in participants who have age related loss of vision in the central part of their eye.
Scientific Title of Study
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
Trial Acronym
ShORe
Secondary IDs if Any
Secondary ID
Identifier
2020â€004736â€24
EudraCT
OPT-302-1004, Version: 1.0, dated 16th December 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
inVentiv International Pharma Services Private Limited
4th Floor, Block-2, DLF Downtown, Commercial Site, Block-V, DLF City, Phase III, Sector-25A, Gurugram – 122002
Countries of Recruitment
Argentina Australia Brazil Bulgaria Canada Czech Republic Denmark France Germany Greece Hungary India Israel Italy Latvia Malaysia Poland Republic of Korea Russian Federation Spain Thailand Ukraine United Kingdom United States of America
Institutional Ethics Committee Regional Institute Of Ophthalmology,88 College Street, Kolkata- 700073, West Bengal.
Approved
Institutional Ethics Committee, B J Medical College and Civil Hospital, Office of medical superintendent, Civil Hospital, Ahmedabad- 380016, Gujarat
Submittted/Under Review
Institutional Ethics Committee, JSS Medical College and Hospital, Sri Shivarathreeshwara Nagar, Mysore- 570015, Karnataka,
Approved
Institutional Ethics Committee, PBMAs H. V. Desai Eye Hospital, S. No. 93 Tarawade Vasti, Mohammdwadi Road, Hadapsar Pune- 411060, Maharashtra
Submittted/Under Review
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, T C Eye Center, B 5/36, Vinay Khand Gomti Nagar Lucknow, Uttar Pradesh
Approved
Medilink Ethics Committee, Medilink Hospital Research Centre, 132 feet Ring Road, Near Ahyamal Cross Road, Ahmedabad - 380015, Gujarat,
Experimental: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.
2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.
• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
ExclusionCriteria
Details
• Any previous treatment for neovascular AMD.
• Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
• Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Baseline to Week 52
Secondary Outcome
Outcome
TimePoints
1.Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
2.Proportion of participants gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
3.Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by SD-OCT
4.Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
5. Change in central sub-field thickness (CST) by spectral domain optical coherence tomography (SD-OCT)
6.Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score
Safety:
1.Incidence of ocular and non-ocular TEAEs
2.Proportion of participants losing 15 or more ETDRS BCVA letters from Baseline to Week 52
3.Participant incidence of ADA formation.
Pharmacokinetic:
1.OPT-302 pharmacokinetic parameters.
[ Time Frame: Baseline to Week 52]
Target Sample Size
Total Sample Size="990" Sample Size from India="49" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study is a Phase 3,
multicentre, randomised, parallel-group, sham-controlled, double-masked, study
of approximately 102 weeks in duration. Eligible study participants will be
randomised at Baseline to one of three treatment arms in a 1:1:1 ratio:
intravitreal ranibizumab followed by Standard Dosing 2.0 mg OPT-302;
intravitreal ranibizumab followed by Extended Dosing 2.0 mg OPT-302; or
intravitreal ranibizumab followed by a sham injection. The study has two
phases, the Efficacy Phase (Baseline to Week 52 [Visit 15]) and the Safety
Phase (Week 52 to Week 100 [Visit 15 to Visit 27]). Although efficacy and
safety will be assessed during both study phases, the efficacy of OPT-302 is
intended to be characterised during the Efficacy Phase (via the primary and
secondary efficacy endpoints), and the safety of OPT-302 after long term (2
year) administration is intended to be characterised during the Safety Phase.