Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection (ONYX)
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| ClinicalTrials.gov Identifier: NCT02713204 |
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Recruitment Status :
Completed
First Posted : March 18, 2016
Last Update Posted : October 20, 2017
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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Brief Summary:
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neovascular Age-Related Macular Degeneration | Drug: REGN910-3 Drug: Intravitreal Aflibercept Injection (IAI) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 365 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-Masked, Active-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Neovascular Age-Related Macular Degeneration |
| Actual Study Start Date : | March 2016 |
| Actual Primary Completion Date : | October 3, 2017 |
| Actual Study Completion Date : | October 3, 2017 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Age-related macular degeneration
MedlinePlus related topics:
Macular Degeneration
Drug Information available for:
Aflibercept
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1
Participants in Group 1 will receive REGN910-3 dosing regimen 1
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Drug: REGN910-3 |
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Experimental: Group 2
Participants in Group 2 will receive REGN910-3 dosing regimen 2
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Drug: REGN910-3 |
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Active Comparator: Group 3
Participants in Group 3 will receive IAI
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Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
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Primary Outcome Measures :
- Change from baseline in BCVA measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
Secondary Outcome Measures :
- Change from baseline in central subfield retinal thickness (CST) at week 12 through week 36 as measured by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to week 36 ]
- Change in choroidal neovascularization (CNV) area from baseline [(measured by fluorescein angiography (FA)] at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
- Change in total lesion area from baseline (measured by FA) at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
Other Outcome Measures:
- Proportion of patients with no retinal and/or subretinal fluid at week 12 through week 36 [ Time Frame: Baseline to week 36 ]
- Time to no retinal and/or subretinal fluid through week 36 [ Time Frame: Baseline to week 36 ]
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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
Key Inclusion Criteria:
- Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
- BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
- Willing and able to comply with clinic visits and study-related procedures.
- Provide signed informed consent.
Key Exclusion Criteria:
- Evidence of CNV due to any cause other than AMD in either eye
- Prior IVT anti-VEGF in the study eye
- Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
- Any history of macular hole of stage 2 and above in the study eye
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): NCT02713204
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02713204 History of Changes |
| Other Study ID Numbers: |
R910-3-AMD-1517 |
| First Posted: | March 18, 2016 Key Record Dates |
| Last Update Posted: | October 20, 2017 |
| Last Verified: | October 2017 |
Additional relevant MeSH terms:
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Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Endothelial Growth Factors Growth Substances Physiological Effects of Drugs |