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Completed

NCT Number: NCT00973011

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

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).

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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability and willingness to undertake all scheduled visits and assessments
  • Agreement to use an effective form of contraception for the duration of the study
  • Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)

Exclusion criteria

  • Treatment for active systemic infection
  • Predisposition or history of increased risk for infection
  • Active malignancy
  • History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
  • GA in either eye due to non-AMD causes
  • Active or history of ocular and intraocular conditions in the study eye (except GA)
  • History of vitreoretinal surgery or laser photocoagulation in the study eye
  • Prior treatment for AMD (except vitamins and minerals)
  • History of intravitreal (ITV) drug delivery
  • Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Treatment and study plan

FCFD4514S

Drug

Intravitreal escalating dose

Primary outcomes

  1. Safety and tolerability of the study drug

    Time frame: Through study completion or early study discontinuation

Secondary outcomes

  1. PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)

    Time frame: Through study completion or early study discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

A Phase Ia, Multicenter, Open-Label, Single-Dose, Dose-Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 9, 2009
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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