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

Overview

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

Full Title of Study: “A Phase 2b 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2019

Detailed Description

Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose groups:

- Zimura Dose Administration 1

- Zimura Dose Administration 2

- Sham Administration 1

Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose groups:

- Zimura Dose Administration 3

- Zimura Dose Administration 4

- Sham Administration 2

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

Interventions

  • Drug: Zimura
    • Zimura Dose Administration 1
  • Drug: Zimura
    • Zimura Dose Administration 2
  • Other: Sham
    • Sham Administration 1
  • Drug: Zimura
    • Zimura Dose Administration 3
  • Drug: Zimura
    • Zimura Dose Administration 4
  • Other: Sham
    • Sham Administration 2

Arms, Groups and Cohorts

  • Experimental: Dose Group 1
    • Zimura Dose Administration 1
  • Experimental: Dose Group 2
    • Zimura Dose Administration 2
  • Sham Comparator: Dose Group 3
    • Sham Administration 1
  • Experimental: Dose Group 4
    • Zimura Dose Administration 3
  • Experimental: Dose Group 5
    • Zimura Dose Administration 4
  • Sham Comparator: Dose Group 6
    • Sham Administration 2

Clinical Trial Outcome Measures

Primary Measures

  • Change in geographic atrophy (GA)
    • Time Frame: 12 months
    • Mean rate of change in GA measured by fundus autofluorescence (FAF)

Secondary Measures

  • Best Corrected Visual Acuity (BCVA)
    • Time Frame: 12 months
    • Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)

Participating in This Clinical Trial

Inclusion Criteria

  • Subjects 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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ophthotech Corporation
  • Provider of Information About this Clinical Study
    • Sponsor

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