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

Conditions

Geographic Atrophy

Brief summary

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.

Sadda S, Hatcher KA, Shah BK, Kondapalli SS, Li C, Baumal CR.

2025-05-19

10.1007/s40123-025-01156-5

Deep Learning to Predict Geographic Atrophy Area and Growth Rate from Multimodal Imaging.

Anegondi N, Gao SS, Steffen V, Spaide RF, Sadda SR, Holz FG, Rabe C, Honigberg L, Newton EM, Cluceru J, Kawczynski MG, Bengtsson T, Ferrara D, Yang Q.

2022-08-2831 citations

10.1016/j.oret.2022.08.018

Reliability and Construct Validity of the NEI VFQ-25 in a Subset of Patients With Geographic Atrophy From the Phase 2 Mahalo Study.

Sivaprasad S, Tschosik E, Kapre A, Varma R, Bressler NM, Kimel M, Dolan C, Silverman D.

2018-03-1042 citations

10.1016/j.ajo.2018.03.006

Functional Reading Independence (FRI) Index: A New Patient-Reported Outcome Measure for Patients With Geographic Atrophy.

Kimel M, Leidy NK, Tschosik E, Dolan C, Souied EH, Varma R, Bressler NM.

2016-11-0135 citations

10.1167/iovs.16-20361

Outer retinal tubulation as a predictor of the enlargement amount of geographic atrophy in age-related macular degeneration.

Hariri A, Nittala MG, Sadda SR.

2014-10-1249 citations

10.1016/j.ophtha.2014.08.035

Interventions

DRUGFCFD4514S

Repeating intravitreal injection

DRUGsham

Repeating sham injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

60 Years to 89 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Growth rate of geographic atrophy (GA) lesion area from baseline	Month 18

Secondary

Measure	Time frame
Mean change in best corrected visual acuity (BCVA) from baseline	Month 18

Countries

Germany, United States

Outcome results

None listed