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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Drug: FCFD4514S


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: FCFD4514S<br>* Intravitreal escalating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of the study drug |  | Through study completion or early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GA