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Phase 3 N=286 Randomized Double-blind Treatment

Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Geographic Atrophy · Dry Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT02686658 ↗
Enrolled (actual)
286
Serious AEs
22.4%
Results posted
May 2023
Primary outcome: Primary: Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence — 0.292; 0.402; 0.321; 0.444 millimeters (mm) — p=0.0072

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Avacincaptad Pegol (Drug); Sham (Other)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
IVERIC bio, Inc.
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence		 0.292; 0.402; 0.321; 0.444 0.0072 sig
SECONDARY
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters		 -7.90; -9.29; -3.79; -3.51 0.3464
SECONDARY
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters		 -1.03; -1.41; 1.53; 2.97 0.8405

Summary

The objectives of this study were to evaluate the safety and efficacy of Zimura intravitreal (IVT) administration when administered in participants with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).

Eligibility Criteria

Inclusion Criteria

  • Participants of either gender aged ≥ 50 years
  • Diagnosis of Non-foveal GA secondary to dry AMD

Exclusion Criteria

  • Evidence of Choroidal Neovascularization (CNV)
  • GA secondary to any condition other than AMD
  • Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals
  • Any intraocular surgery or thermal laser within three (3) months of trial entry
  • Any prior thermal laser in the macular region, regardless of indication
  • Any ocular or periocular infection in the twelve (12) weeks
  • Previous therapeutic radiation in the region of the study eye
  • Any sign of diabetic retinopathy in either eye
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02686658). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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