A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

• ClinicalTrials.gov Identifier: NCT03345082
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Last Update Posted: January 12, 2021
• Sponsor: Opthea Limited
• Information provided by (Responsible Party): Opthea Limited

Tracking Information

• First Submitted Date: November 14, 2017
• First Posted Date: November 17, 2017
• Last Update Posted Date: January 12, 2021
• Actual Study Start Date: November 6, 2017
• Actual Primary Completion Date: May 14, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 14, 2017): Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) [ Time Frame: Baseline to Week 24 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 14, 2017)

• Proportion of participants gaining 15 or more ETDRS BCVA letters [ Time Frame: Baseline to Week 24 ]
• Area under the ETDRS BCVA over time curve [ Time Frame: Baseline to Week 24 ]
• Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 24 ]
• Change in intra-retinal fluid and sub-retinal fluid on SD-OCT [ Time Frame: Baseline to Week 24 ]
• Proportion of participants losing 15 or more letters (on ETDRS BCVA chart) [ Time Frame: Baseline to Week 24 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
• Official Title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)
• Brief Summary: A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• 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: OPT-302
  Intravitreal injection
• Biological: ranibizumab
  Intravitreal injection
  Other Name: Lucentis
• Other: sham intravitreal injection
  Sham (mock) intravitreal injection

Study Arms

• Experimental: 0.5 mg ranibizumab with 2.0 mg OPT-302
  0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
  Interventions:

  • Biological: OPT-302
  • Biological: ranibizumab
• Experimental: 0.5 mg ranibizumab with 0.5 mg OPT-302
  0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
  Interventions:

  • Biological: OPT-302
  • Biological: ranibizumab
• Sham Comparator: 0.5 mg ranibizumab with sham
  0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
  Interventions:

  • Biological: ranibizumab
  • Other: sham intravitreal injection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 26, 2018): 366
• Original Estimated Enrollment (submitted: November 14, 2017): 351
• Actual Study Completion Date: May 14, 2019
• Actual Primary Completion Date: May 14, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
• An ETDRS BCVA score between 60 and 25 (inclusive) letters

Exclusion Criteria:

• Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
• Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
• Poorly controlled diabetes mellitus (defined as HbA1c>7%)
• Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for 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: Czechia, France, Hungary, Israel, Italy, Latvia, Poland, Spain, United Kingdom, United States

Administrative Information

• NCT Number: NCT03345082
• Other Study ID Numbers: OPT-302-1002
• 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: Not Provided
• 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

• Study Director: Study Director; Opthea Limited

• PRS Account: Opthea Limited
• Verification Date: January 2020