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Clinical Trial Results:
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

Summary
EudraCT number	2015-003991-56
Trial protocol	HU LV EE HR
Global end of trial date	23 Apr 2020

Results information
Results version number	v1(current)
This version publication date	15 Jul 2022
First version publication date	15 Jul 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

OPH2003

ISRCTN number

US NCT number

NCT02686658

WHO universal trial number (UTN)

Sponsor organisation name

IVERIC bio, Inc.

Sponsor organisation address

1249 South River Road, Suite 107, Cranbury, United States, NJ 08512

Public contact

Medical Director, IVERIC bio, Inc., clinicaltrials@ivericbio.com

Scientific contact

Medical Director, IVERIC bio, Inc., clinicaltrials@ivericbio.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

19 May 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

15 Oct 2019

Global end of trial reached?

Yes

Global end of trial date

23 Apr 2020

Was the trial ended prematurely?

Main objective of the trial

The objectives of this study were to evaluate the safety and efficacy of Zimura™ intravitreal administration when administered in subjects with geographic atrophy secondary to age-related macular degeneration (AMD). The study design was based on the screening study methodology presented in Fleming and Richardson 2004. By pre-specification, Screening analysis was performed to assess whether the effect of Zimura on the mean rate of GA growth was plausibly more efficacious (or reliably more efficacious) than that of the Sham control on the mean rate of GA growth over 12 months.

Protection of trial subjects

Before initiation of the study, the protocol and the patient informed consent provisions were reviewed and approved by the appropriate Independent Ethics Committees (IECs) or Institutional Review Boards (IRBs) for each of the centers involved in the study according to national or local regulations and in accordance with the United States (US) Food and Drug Administration (FDA) Title 21, Code of Federal Regulations Parts 56.107 through 56.115, the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) guidelines (Committee for Proprietary Medicinal Products/ICH/135/95), or local laws. Study initiation at each site began only after receiving written approval from the IEC/IRB. The protocol amendments were reviewed and approved by the appropriate IECs or IRBs for each of the centers. The study was conducted in full compliance with the principles of the Declaration of Helsinki, as adopted in 1964 by the 18th World Medical Assembly and amended in Tokyo, Venice, Hong Kong, South Africa, and Scotland, and in compliance with the respective law and regulations of the country in which the research was conducted. In addition, the study was performed in line with the principles outlined in the Guideline for GCP (ICH E6), the ICH Tripartite Guideline (May 1997), and US FDA regulations. Prior to study entry, all patients were informed fully of the nature and aims of the study. Ample time was provided for patients to read the patient information sheet and ask any questions regarding the investigational drug. Patients were informed that their participation was voluntary and that they could withdraw from the study at any time for any reason without incurring any penalty or withholding of treatment on the part of the investigator. Before receiving any treatment related to this study, all patients provided their written informed consent.

Background therapy

Evidence for comparator

Actual start date of recruitment

20 Jan 2016

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country