Phase 3 N=448 Randomized Double-blind Treatment

A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)

Geographic Atrophy · Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT04435366 ↗

Enrolled (actual)

448

Serious AEs

15.0%

Results posted

Dec 2023

Primary outcome: Primary: The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 — 0.336; 0.392 millimeters (mm)/year — p=0.0064

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Avacincaptad Pegol (Drug); Sham (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: All
Sponsor: IVERIC bio, Inc.
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12	0.336; 0.392	0.0064 sig
PRIMARY The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24	2.23; 2.10; 2.59	0.0165 sig
SECONDARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months	-7.31; -6.48	0.58
SECONDARY Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months	-10.58; -9.1	0.38
SECONDARY Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months	-1.2; -1.6; -3.4; -3.6; -5.4; -4.7	—
SECONDARY Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months	-7.735; -7.023	0.5929
SECONDARY Number of Participants With Categorical One-level Loss in VFQ-25 Subscale	45; 35; 56; 43; 61; 49	—
SECONDARY Time to Persistent Vision Loss	17.02; 13.93	0.6424

Summary

The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Any prior treatment for AMD (dry or wet) 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 3 months of trial entry.
Any prior thermal laser in the macular region, regardless of indication
Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 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 (NCT04435366). 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.