Clinical trial

A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy

Name

OPH1005

Description

The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.

Trial arms

Trial start

2014-07-01

Estimated PCD

2016-12-01

Trial end

2016-12-01

Status

Terminated

Phase

Early phase I

Treatment

Fovista® (anti-PDGF BB) plus anti-VEGF

Arms:

Fovista® plus anti-VEGF Pre-Treatment, Fovista® plus anti-VEGF Simultaneous

Other names:

Fovista®, anti-VEGF

Size

101

Primary endpoint

Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)

2 years

Number of Subjects With Serious Adverse Events

2 years

Eligibility criteria

Inclusion Criteria: * Subjects of either gender aged ≥ 50 years * All fluorescein angiographic subtypes with presence of active choroidal neovascularization 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': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 101, 'type': 'ACTUAL'}}

Updated at

2024-02-23

1 organization

1 product

1 indication

Organization

Ophthotech

Product

Fovista

Indication

Macular Degeneration