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

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ClinicalTrials.gov Identifier: NCT04757610
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : November 30, 2023
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Tracking Information
First Submitted Date  ICMJE February 12, 2021
First Posted Date  ICMJE February 17, 2021
Last Update Posted Date November 30, 2023
Actual Study Start Date  ICMJE March 12, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2021)		 Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters [ Time Frame: Baseline to Week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2021)
  • 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 ]
  • 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 ]
  • Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by 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 sub-field 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
Official Title  ICMJE 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
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE
  • Biological: 2.0 mg OPT-302
    intravitreal injection
  • Biological: 0.5 mg ranibizumab
    intravitreal injection
  • Procedure: Sham
    intravitreal injection
Study Arms  ICMJE
  • 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.

    Interventions:
    • Biological: 2.0 mg OPT-302
    • Biological: 0.5 mg ranibizumab
  • 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.

    Interventions:
    • Biological: 2.0 mg OPT-302
    • Biological: 0.5 mg ranibizumab
  • 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.

    Interventions:
    • Biological: 0.5 mg ranibizumab
    • Procedure: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 15, 2021)		 990
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Opthea Limited +61 3 9826 0399 info@opthea.com
Listed Location Countries  ICMJE Argentina,   Australia,   Brazil,   Bulgaria,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Latvia,   Malaysia,   Poland,   Spain,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT04757610
Other Study ID Numbers  ICMJE OPT-302-1004
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Opthea Limited
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Opthea Limited
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Opthea Limited
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP