A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)

Condition(s) studied

Investigational drug(s) / intervention(s)

JNJ-81201887: No study intervention will be administered as part of this LTE study.

Sham Procedure: No study intervention will be administered as part of this LTE study.

Study summary

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Eligibility

Primary outcome measure(s)

• Number of Participants with Ocular and Systemic Treatment-emergent Adverse Events (TEAEs) — Upto 5 Years
  Number of participants with ocular and systemic TEAEs will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as any adverse event occurring at or after the administration of study intervention.
• Number of Participants with Abnormal Findings in Clinical Laboratory Assessments — Upto 5 Years
  Number of participants with abnormal findings in clinical laboratory Assessments (including hematology and clinical chemistry) will be reported.
• Number of Participants with Abnormal Findings in Retinal imaging and Eye Examinations — Upto 5 Years
  Number of participants with abnormal findings in retinal imaging (Fundus Autofluorescence, Spectral Domain Optical Coherence Tomography) and eye examinations will be reported.
• Change from Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score — Baseline up to 42 months
  BCVA will be assessed using the ETDRS chart at a starting distance of 4 meters. The ETDRS score ranges from 0 to 100 letters, where an increase in the number of letters read correctly means that vision has improved and vice-versa.

Trial sites (104)

+ 64 more sites — see the full list on the official registry below.

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