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OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD) (ShORe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04757610
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : September 8, 2022
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: 0.5 mg ranibizumab 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 Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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 at 4-weekly intervals.

 Biological: 2.0 mg OPT-302
intravitreal injection

Biological: 0.5 mg ranibizumab
intravitreal injection
Experimental: 0.5 mg ranibizumab with Extended 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 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: 0.5 mg ranibizumab
intravitreal injection
Sham Comparator: 0.5 mg ranibizumab with sham

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals.

Sham intravitreal injection administered at 4-weekly intervals.

 Biological: 0.5 mg ranibizumab
intravitreal injection

Procedure: Sham
intravitreal injection


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

Secondary Outcome Measures :
  1. Proportion of participants gaining 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
  2. Proportion of participants gaining 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
  3. Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by SD-OCT [ Time Frame: at Week 52 ]
  4. Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) [ Time Frame: Baseline to Week 52 ]
  5. Change in central sub-field thickness (CST) by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 52 ]
  6. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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): NCT04757610


Contacts
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Contact: Opthea Limited +61 3 9826 0399 info@opthea.com

Locations
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Sponsors and Collaborators
Opthea Limited
More Information
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Additional Information:

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Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT04757610    
Other Study ID Numbers: OPT-302-1004
First Posted: February 17, 2021    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
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
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents