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

Macular Degeneration Clinical Trial

Official title:

A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686658
• Other study ID #: OPH2003
• Secondary ID: 2015-003991-56
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 20, 2016
• Est. completion date: April 23, 2020

Study information

• Verified date: April 2023
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 23, 2020
• Est. primary completion date: September 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection

Other:
• Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection.

Locations

Country	Name	City	State
Croatia	Clinical hospital center Osijek	Osijek
Czechia	Fakultni Nemocnice Brno	Brno
Czechia	Faculty Hospital Hradec Kralove	Hradec Králové
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Axon Clinical SRO	Praha
Estonia	Dr.Kai Noor Eye Clinic	Tallinn
Estonia	East Tallinn Central Hospital	Tallinn
Hungary	Peterfy Korhaz-Rendelointezet Orszagos Traumatologiai Intezet	Budapest
Israel	Rambam Medical Center	Haifa
Israel	Hadassah University Hospital	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah tikva
Israel	Kaplan Medical Center	Re?ovot
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Latvia	Pauls Stradins Clinical University Hospital	Riga
United States	Retina Consultants of Hawaii	'Aiea	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
IVERIC bio, Inc.

Countries where clinical trial is conducted

United States,  Croatia,  Czechia,  Estonia,  Hungary,  Israel,  Latvia, 

References & Publications (1)

Jaffe GJ, Westby K, Csaky KG, Mones J, Pearlman JA, Patel SS, Joondeph BC, Randolph J, Masonson H, Rezaei KA. C5 Inhibitor Avacincaptad Pegol for Geographic Atrophy Due to Age-Related Macular Degeneration: A Randomized Pivotal Phase 2/3 Trial. Ophthalmolo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	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.	Baseline and 12 months
Secondary	Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	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.	Baseline and 12 months
Secondary	Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	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.	Baseline and 12 months