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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00973011

Enrollment

Registered

2009-09-09

Start date

2009-09-30

Completion date

2010-07-31

Last updated

2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geographic Atrophy

Keywords

Brief 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).

Interventions

DRUGFCFD4514S

Intravitreal escalating dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of the study drug	Through study completion or early study discontinuation

Secondary

Measure	Time frame
PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)	Through study completion or early study discontinuation

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026