A clinical study to compare the safety and effectiveness of study drug (OPT-302) in combination with aflibercept, compared with aflibercept alone 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 Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD) - COAST

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/10/037507

Enrollment

990

Registered

2021-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

None listed

Interventions

Intervention1: Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302 2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-wee

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. Main 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.

Exclusion criteria

Exclusion criteria: Main 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 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 Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 2.Proportion of participants gaining 15 or more Early Treatment 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 spectral domain optical coherence tomography (SD-OCT) 4.Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) 5.Change in central subfield 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 Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function. Timepoint: [ Time Frame: Baseline to Week 52]	—

Measure

Time frame

1.Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 2.Proportion of participants gaining 15 or more Early Treatment 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 spectral domain optical coherence tomography (SD-OCT) 4.Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) 5.Change in central subfield 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 Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function. Timepoint: [ Time Frame: Baseline to Week 52]

—

Countries

Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Latvia, Lithuania, Netherlands, Philippines, Poland, Republic of Korea, Slovakia, Spain, Taiwan, United Kingdom, United States of America

Contacts

Public ContactAtaur Rahman

Inventiv International Pharma Services Private Limited (Syneos Health)

bhawana.awasthy@syneoshealth.com9560692103

Outcome results