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OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD) (COAST)

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ClinicalTrials.gov Identifier: NCT04757636
Recruitment Status : Active, not recruiting
First Posted : February 17, 2021
Last Update Posted : March 28, 2024
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Study Description
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Brief Summary:
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: 2.0 mg OPT-302 Biological: 2.0 aflibercept Procedure: Sham Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 nAMD
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2026

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Arms and Interventions
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Arm Intervention/treatment
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-weekly intervals.

2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.

 Biological: 2.0 mg OPT-302
intravitreal injection

Biological: 2.0 aflibercept
intravitreal injection
Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302

2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-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.

 Biological: 2.0 mg OPT-302
intravitreal injection

Biological: 2.0 aflibercept
intravitreal injection
Sham Comparator: 2.0 mg aflibercept with sham

2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.

Sham intravitreal injection administered at 4-weekly intervals.

 Biological: 2.0 aflibercept
intravitreal injection

Procedure: Sham
intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]

Secondary Outcome Measures :
  1. Proportion of participants gaining 15 or more ETDRS BCVA letters [ Time Frame: Baseline to Week 52 ]
  2. Proportion of participants gaining 10 or more ETDRS BCVA letters [ Time Frame: Baseline to Week 52 ]
  3. Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ]
  4. Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT [ Time Frame: at Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04757636


Locations
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Sponsors and Collaborators
Opthea Limited
More Information
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Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT04757636    
Other Study ID Numbers: OPT-302-1005
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: March 28, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Aflibercept
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents