Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD

NCT ID: NCT02214628

Last Updated: 2024-02-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).

Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fovista® plus anti-VEGF Simultaneous

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Fovista® plus anti-VEGF Pre-Treatment

Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Other Intervention Names

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Fovista® anti-VEGF

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ophthotech Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix, Arizona, United States

Site Status

Beverly Hills, California, United States

Site Status

Sacramento, California, United States

Site Status

Sacramento, California, United States

Site Status

Santa Ana, California, United States

Site Status

Augusta, Georgia, United States

Site Status

Oak Forest, Illinois, United States

Site Status

Boston, Massachusetts, United States

Site Status

Jackson, Michigan, United States

Site Status

Minneapolis, Minnesota, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Ladson, South Carolina, United States

Site Status

Abilene, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OPH1005

Identifier Type: -

Identifier Source: org_study_id

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