Safety Study of Zimura™in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD

Macular Degeneration Clinical Trial

Official title:

A Phase 2A Randomized Open-Label Controlled Trial to Assess the Safety of Zimura™ (Anti-C5 Aptamer) Administered in Combination With Anti-VEGF Therapy in Treatment Experienced Patients With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05571267
• Other study ID #: OPH2004
• Status: Terminated
• Phase: Phase 2
• Start date: October 20, 2016
• Est. completion date: April 24, 2018

Study information

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

Clinical Trial Summary

The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Treatment experienced subjects defined as subjects with 1 prior dose of same intravitreal anti-VEGF therapy given within the past 8 weeks for neovascular age-related macular degeneration (NVAMD) in the study eye. There must be < 0 letters of improvement in Snellen (not ETDRS Snellen equivalent) visual acuity since the start of anti-VEGF treatment.

• Presence of subfoveal active choroidal neovascularization (CNV)

Exclusion Criteria:

• Intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication, with the exception of the 1 prior anti-VEGF injections.

• Presence of other causes of choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.

• Non-pharmacologic treatment (intraocular surgery or thermal laser) within three months of trial entry.

• Prior thermal laser in the macular region, regardless of indication.

• Ocular or periocular infection in the past twelve weeks.

• History of any of the following conditions or procedures in the study eye:

rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery, glaucoma drainage device, or corneal transplant.

• Previous therapeutic radiation in the region of the study eye.

• Evidence of diabetic retinopathy

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Zimura
Zimura 2 mg, administered by intravitreal injection
• Avastin
Avastin 1.25 mg, administered by intravitreal injection
• Lucentis
Lucentis 0.5 mg, administered by intravitreal injection
• Eylea
Eylea 2 mg, administered by intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVERIC bio, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With >0 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.; Observed VA loss at Month 12 from Day 1 was assessed.	Month 12
Primary	Percentage of Participants With >0 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters.; Observed VA loss at Month 18 from Day 1 was assessed.	Month 18
Primary	Percentage of Participants With >5 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.; Observed VA loss at Month 12 from Day 1 was assessed.	Month 12
Primary	Percentage of Participants With >5 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.; Observed VA loss at Month 18 from Day 1 was assessed.	Month 18
Primary	Percentage of Participants With >10 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.; Observed VA loss at Month 12 from Day 1 was assessed.	Month 12
Primary	Percentage of Participants With >10 Letter Loss	Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters.; Observed VA loss at Month 18 from Day 1 was assessed.	Month 18