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

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

Tracking Information

• First Submitted Date: February 12, 2021
• First Posted Date: February 17, 2021
• Last Update Posted Date: March 28, 2024
• Actual Study Start Date: March 12, 2021
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 15, 2021): Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 26, 2024)

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

Original Secondary Outcome Measures (submitted: February 15, 2021)

• 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
• 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
• Brief Summary: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neovascular Age-related Macular Degeneration

Intervention

• Biological: 2.0 mg OPT-302
  intravitreal injection
• Biological: 2.0 aflibercept
  intravitreal injection
• Procedure: Sham
  intravitreal injection

Study Arms

• 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.

  Interventions:

  • Biological: 2.0 mg OPT-302
  • Biological: 2.0 aflibercept
• 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.

  Interventions:

  • Biological: 2.0 mg OPT-302
  • Biological: 2.0 aflibercept
• 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.

  Interventions:

  • Biological: 2.0 aflibercept
  • Procedure: Sham

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 15, 2021): 990
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2026
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Brazil, Bulgaria, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Republic of, Latvia, Lithuania, Netherlands, Philippines, Poland, Puerto Rico, Slovakia, Spain, Taiwan, United Kingdom, United States
• Removed Location Countries: Slovenia

Administrative Information

• NCT Number: NCT04757636
• Other Study ID Numbers: OPT-302-1005
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Opthea Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: Opthea Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Opthea Limited
• Verification Date: March 2024