A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneration

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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004694-46-DK

Enrollment

990

Registered

2021-06-11

Start date

2021-11-19

Completion date

Unknown

Last updated

2024-03-18

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

Conditions

Neovascular Age-related Macular Degeneration (wet AMD) MedDRA version: 20.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: PT Classification code 10071129 Term: Neovascular age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 20.1 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Product Name: OPT-302 Product Code: OPT-302 Pharmaceutical Form: Solution for injection INN or Proposed INN: Vascular endothelial growth factor receptor-3 (VEGFR-3) derivative fused to a human immunog

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Male or female participants at least 50 years of age. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 890

Exclusion criteria

Exclusion criteria: Study Eye • 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. Note: other protocol exclusion criteria may also apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD.;Secondary Objective: The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept from Baseline to (and at) Week 52 as determined by: Efficacy: • Changes in ETDRS BCVA letter score • Changes in anatomical parameters (CNV area, CST, SRF and IR cysts) • Changes in National Eye Institute 25-item Vision Function Questionnaire (NEI-VFQ-25). Participant Reported Outcomes (PROs). Safety: • Incidence of adverse events (AEs) • Deterioration in ETDRS BCVA letter score • Incidence of ADA formation. Pharmacokinetic: • Pharmacokinetic parameters of OPT-302.;Primary end point(s): Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] ;Timepoint(s) of evaluation of this end point: 52 Weeks	—

Measure

Time frame

Main Objective: To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular AMD.;Secondary Objective: The secondary objectives of the study are to determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept from Baseline to (and at) Week 52 as determined by: Efficacy: • Changes in ETDRS BCVA letter score • Changes in anatomical parameters (CNV area, CST, SRF and IR cysts) • Changes in National Eye Institute 25-item Vision Function Questionnaire (NEI-VFQ-25). Participant Reported Outcomes (PROs). Safety: • Incidence of adverse events (AEs) • Deterioration in ETDRS BCVA letter score • Incidence of ADA formation. Pharmacokinetic: • Pharmacokinetic parameters of OPT-302.;Primary end point(s): Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] ;Timepoint(s) of evaluation of this end point: 52 Weeks

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Secondary

Measure	Time frame
Secondary end point(s): Efficacy • Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] • Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: at Week 52 ] • Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ] • Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 52 ] • Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score [ Time Frame: Baseline to Week 52 ] • Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.;Timepoint(s) of evaluation of this end point: 52 Weeks	—

Measure

Time frame

Secondary end point(s): Efficacy • Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] • Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ] • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: at Week 52 ] • Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ] • Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 52 ] • Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score [ Time Frame: Baseline to Week 52 ] • Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.;Timepoint(s) of evaluation of this end point: 52 Weeks

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Countries

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

Contacts

Public ContactClinical Development Director

Opthea Limited

Annette.leahy@opthea.com+61398260399

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026