A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
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| ClinicalTrials.gov Identifier: NCT03345082 |
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Recruitment Status :
Completed
First Posted : November 17, 2017
Last Update Posted : January 12, 2021
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Sponsor:
Opthea Limited
Information provided by (Responsible Party):
Opthea Limited
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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 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
MedlinePlus Genetics related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information
available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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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)
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Biological: OPT-302
Intravitreal injection Biological: ranibizumab Intravitreal injection
Other Name: Lucentis |
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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
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Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis Other: sham intravitreal injection Sham (mock) intravitreal injection |
Primary Outcome Measures :
- Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) [ Time Frame: Baseline to Week 24 ]
Secondary Outcome Measures :
- 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 ]
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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
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
Show 108 study locations
Sponsors and Collaborators
Opthea Limited
Investigators
| Study Director: | Study Director | Opthea Limited |
| 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 |
| 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 |