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.

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) - ShORe

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037451

Enrollment

990

Registered

2021-10-21

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: 0.5 mg ranibizumab with Standard 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

Eligibility

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

Measure	Time frame
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) lettersTimepoint: Baseline to Week 52	—

Secondary

Measure	Time frame
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. Timepoint: [ Time Frame: Baseline to Week 52]	—

Measure

Time frame

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. Timepoint: [ Time Frame: Baseline to Week 52]

—

Countries

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

Contacts

Public ContactAtaur Rahman

Inventiv International Pharma Services Private Limited

bhawana.awasthy@syneoshealth.com9560692103

Outcome results