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Clinical trial

OPH1006

ID
Name
OPH1006
Description
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
Trial arms
Trial start
2016-04-26
Estimated PCD
2017-01-01
Trial end
2017-01-01
Status
Terminated
Phase
Early phase I
Treatment
Fovista®
Arms:
Fovista® plus aflibercept, Fovista® plus bevacizumab, Fovista® plus ranibizumab
bevacizumab
Arms:
Fovista® plus bevacizumab
Other names:
Avastin®
ranibizumab
Arms:
Fovista® plus ranibizumab
Other names:
Lucentis®
aflibercept
Arms:
Fovista® plus aflibercept
Other names:
Eylea®
Size
63
Primary endpoint
Total Numer of Systemic Adverse Events
2 years
Total Number of Other Adverse Events (>5%)
2 years
Eligibility criteria
Inclusion Criteria: * Subjects of either gender aged ≥ 50 years. * Active subfoveal choroidal neovascularization (CNV) due to AMD. Exclusion Criteria: * Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication. * Subjects with subfoveal scar or subfoveal atrophy * Any ocular or periocular infection in the past twelve (12) weeks. * History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 63, 'type': 'ACTUAL'}}
Updated at
2024-02-23

1 organization

4 products

1 indication

Organization
Ophthotech
Product
bevacizumab
Indication
Age-related macular degeneration
Product
aflibercept
Product
Fovista®
Product
ranibizumab