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Trial record 1 of 1 for:    opthea 1002
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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 12, 2021
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: OPT-302 Biological: ranibizumab Other: sham intravitreal injection Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 6, 2017
Actual Primary Completion Date : May 14, 2019
Actual Study Completion Date : May 14, 2019

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 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)
 Biological: OPT-302
Intravitreal injection

Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis
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)
 Biological: OPT-302
Intravitreal injection

Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis
Sham Comparator: 0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
 Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis

Other: sham intravitreal injection
Sham (mock) 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) [ Time Frame: Baseline to Week 24 ]

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

Eligibility Criteria
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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 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
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): NCT03345082


Locations
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Sponsors and Collaborators
Opthea Limited
Investigators
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Study Director: Study Director Opthea Limited
More Information
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Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT03345082    
Other Study ID Numbers: OPT-302-1002
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2020

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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