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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02686658
Recruitment Status : Active, not recruiting
First Posted : February 19, 2016
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation

Tracking Information
First Submitted Date  ICMJE February 16, 2016
First Posted Date  ICMJE February 19, 2016
Last Update Posted Date November 9, 2018
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
Change in geographic atrophy (GA) [ Time Frame: 12 months ]
Mean rate of change in GA measured by fundus autofluorescence (FAF)
Original Primary Outcome Measures  ICMJE
 (submitted: February 18, 2016)
The mean change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from Baseline to Month 24 [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT02686658 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2017)
Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]
Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Official Title  ICMJE 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
Brief Summary 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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Geographic Atrophy
  • Macular Degeneration
Intervention  ICMJE
  • Drug: Zimura
    Zimura Dose Administration 1
    Other Name: avacincaptad pegol
  • Drug: Zimura
    Zimura Dose Administration 2
    Other Name: avaincaptad pegol
  • Other: Sham
    Sham Administration 1
  • Drug: Zimura
    Zimura Dose Administration 3
    Other Name: avacincaptad pegol
  • Drug: Zimura
    Zimura Dose Administration 4
    Other Name: avacincaptad pegol
  • Other: Sham
    Sham Administration 2
Study Arms  ICMJE
  • Experimental: Dose Group 1
    Zimura Dose Administration 1
    Intervention: Drug: Zimura
  • Experimental: Dose Group 2
    Zimura Dose Administration 2
    Intervention: Drug: Zimura
  • Sham Comparator: Dose Group 3
    Sham Administration 1
    Intervention: Other: Sham
  • Experimental: Dose Group 4
    Zimura Dose Administration 3
    Intervention: Drug: Zimura
  • Experimental: Dose Group 5
    Zimura Dose Administration 4
    Intervention: Drug: Zimura
  • Sham Comparator: Dose Group 6
    Sham Administration 2
    Intervention: Other: Sham
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 19, 2017)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 18, 2016)
300
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Croatia,   Czechia,   Estonia,   Hungary,   Israel,   Latvia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02686658
Other Study ID Numbers  ICMJE OPH2003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ophthotech Corporation
Study Sponsor  ICMJE Ophthotech Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ophthotech Corporation
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP