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A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

2014-08-27 03:19:30 | BioPortfolio

Summary

The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).

Study Design

Control: Uncontrolled, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Geographic Atrophy

Intervention

FCFD4514S

Status

Active, not recruiting

Source

Genentech

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:30-0400

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An Extension Study to Evaluate the Long-Term Safety of FCFD4514S in Patients With Geographic Atrophy

This extension to study CFD4870g (GX01456) will assess the long-term safety and tolerability of repeated intravitreal administration of FCFD4514S in patients with geographic atrophy. Patie...

A Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Administered Monthly or Every Other Month to Patients With Geographic Atrophy

This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-co ntrolled study of safety, tolerability, and evidence of activity of FCFD4514S i ntravitreal injections adm...

Study of of APL-2 Therapy in Patients Geographic Atrophy

The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy a...

Evolution and Risk Factors Associated With Geographic Atrophy Progression

Age-related macular degeneration is one of the leading causes of blindness worldwide. The factors that induce the progression of geographic atrophy, the advanced form of dry age-related ma...

Study of Fenretinide in the Treatment of Geographic Atrophy Associated With Dry Age-Related Macular Degeneration

The purpose of this phase II study is to determine the efficacy of fenretinide in the treatment of geographic atrophy (GA) in subjects with the dry form of age-related macular degeneration...

PubMed Articles [1286 Associated PubMed Articles listed on BioPortfolio]

An Acute Injury Model for the Phenotypic Characteristics of Geographic Atrophy.

Geographic atrophy (GA) is the late stage of non-neovascular age-related macular degeneration. A lack of animal models for GA has hampered treatment efforts. Presented herein is a rat model for GA usi...

Local Progression Kinetics of Geographic Atrophy in Age-Related Macular Degeneration Are Associated With Atrophy Border Morphology.

To assess the impact of distinct atrophy border characteristics based on spectral-domain optical coherence tomography (SD-OCT) imaging on local atrophy progression.

HISTOLOGY OF GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION: A Multilayer Approach.

To systematically characterize histologic features of multiple chorioretinal layers in eyes with geographic atrophy, or complete retinal pigment epithelium (RPE) and outer retinal atrophy, secondary t...

MESOPIC AND DARK-ADAPTED TWO-COLOR FUNDUS-CONTROLLED PERIMETRY IN GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION.

To investigate retinal sensitivity in the junctional zone of geographic atrophy (GA) secondary to age-related macular degeneration using patient-tailored perimetry grids for mesopic and dark-adapted t...

New Insights Into the Development and Progression of Geographic Atrophy After Full Thickness Autologous Choroidal Graft.

To investigate if the contiguity between native and transplanted retinal pigment epithelium (RPE) represents a protective factor against the progression of atrophy after autologous choroidal graft. In...

Medical and Biotech [MESH] Definitions

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

Hereditary conditions that feature progressive visual loss in association with optic atrophy. Relatively common forms include autosomal dominant optic atrophy (OPTIC ATROPHY, AUTOSOMAL DOMINANT) and Leber hereditary optic atrophy (OPTIC ATROPHY, HEREDITARY, LEBER).

The area of medicine concerned with the effects on health and disease due to geographic factors such as CLIMATE, environmental conditions, and geographic location.

In evolutionary theory, overlapping geographic distribution of diverging species. In sympatric GENETIC SPECIATION, genetic diversion occurs without geographic separation.

Progressive, autosomal recessive, diffuse atrophy of the choroid, pigment epithelium, and sensory retina that begins in childhood.

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