Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03345082
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Tracking Information
First Submitted Date  ICMJE November 14, 2017
First Posted Date  ICMJE November 17, 2017
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE November 6, 2017
Actual Primary Completion Date May 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  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 A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
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: OPT-302
    Intravitreal injection
  • Biological: ranibizumab
    Intravitreal injection
    Other Name: Lucentis
  • Other: sham intravitreal injection
    Sham (mock) intravitreal injection
Study Arms  ICMJE
  • 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

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

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   France,   Hungary,   Israel,   Italy,   Latvia,   Poland,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03345082
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party Opthea Limited
Study Sponsor  ICMJE Opthea Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Opthea Limited
PRS Account Opthea Limited
Verification Date January 2020

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