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

Phase 2

Completed

• Conditions: Geographic Atrophy; Dry Age-Related Macular Degeneration
• Interventions: Drug: Avacincaptad Pegol; Other: Sham

• Registration Number: NCT02686658
• Lead Sponsor: IVERIC bio, Inc.

Brief 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).

Detailed Description

Participants will receive monthly intravitreal injections of Zimura or Sham for 18 months.

Study Timeline

• Study Start: 2015-12-15
• Study First Submitted: 2016-02-16
• Study First Submitted QC: 2016-02-18
• Study First Posted: 2016-02-19
• Primary Completion: 2019-09-26
• Study Completion: 2020-04-23
• Disposition First Submitted: 2020-09-30
• Disposition First Submitted QC: 2020-10-07
• Disposition First Posted: 2020-10-19
• Results First Submitted: 2023-01-27
• Results First Submitted QC: 2023-04-18
• Results First Posted: 2023-05-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avacincaptad Pegol 1 mg [Part 1]	Avacincaptad Pegol	Participants received 1 mg of Avacincaptad Pegol in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]	Sham	Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
Avacincaptad Pegol 2 mg [Part 1]	Avacincaptad Pegol	Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
Sham [Part 1]	Sham	Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
Avacincaptad Pegol 2 mg (Avacincaptad Pegol 2mg+Sham) [Part 2]	Avacincaptad Pegol	Participants received 2 mg of Avacincaptad Pegol in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
Avacincaptad Pegol 4 mg (Avacincaptad Pegol 2mg+Avacincaptad Pegol 2mg) [Part 2]	Avacincaptad Pegol	Participants received 4 mg of Avacincaptad Pegol in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
Sham (Sham+Sham) [Part 2]	Sham	Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Baseline and 12 months	The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study \[ETDRS\] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Trial Locations

Locations (16)

Fakultni nemocnice Olomouc; 🇨🇿 Olomouc, Czechia

Fakultni Nemocnice Brno; 🇨🇿 Brno, Czechia

Faculty Hospital Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Axon Clinical SRO; 🇨🇿 Praha, Czechia

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Retina Consultants of Hawaii; 🇺🇸 'Aiea, Hawaii, United States

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Clinical hospital center Osijek; 🇭🇷 Osijek, Croatia

Kaplan Medical Center; 🇮🇱 Reẖovot, Israel

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Meir Medical Center; 🇮🇱 Kfar Saba, Israel

Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet; 🇭🇺 Budapest, Hungary

Dr.Kai Noor Eye Clinic; 🇪🇪 Tallinn, Estonia

Rambam Medical Center; 🇮🇱 Haifa, Israel

East Tallinn Central Hospital; 🇪🇪 Tallinn, Estonia