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

Study Overview
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Brief Summary
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This is a Phase Ib/II, multicenter, randomized, single-masked, sham-injection-controlled study of safety, tolerability, and evidence of activity of FCFD4514S intravitreal injections administered monthly or every other month in patients with geographic atrophy.

Official Title
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A Phase Ib/II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Study of Safety, Tolerability, and Evidence of Activity of FCFD4514S Intravitreal Injections Administered Monthly or Every Other Month to Patients With Geographic Atrophy

Conditions
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Geographic Atrophy

Intervention / Treatment
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* Drug: FCFD4514S
* Drug: sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willingness and ability to provide signed Informed Consent; in addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV) Exclusion Criteria: History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye Previous subfoveal focal laser photocoagulation in the study eye Laser photocoagulation in the study eye Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye GA in either eye due to causes other than AMD Diabetic retinopathy in either eye Active or history of wet AMD in either eye History of other disease, metabolic dysfunction, 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 Active malignancy or history of malignancy within the past 5 years Previous participation in any studies of investigational drugs within 3 months preceding Day 0

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 89 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FCFD4514S<br> | Drug: FCFD4514S<br>* Repeating intravitreal injection<br>|
| Sham Comparator: sham<br> | Drug: sham<br>* Repeating sham injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth rate of geographic atrophy (GA) lesion area from baseline |  | Month 18 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in best corrected visual acuity (BCVA) from baseline |  | Month 18 |