A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

• Register: EUCTR
• Last refreshed on: 22 June 2020
• Main ID: EUCTR2015-003991-56-LV
• Date of registration: 03/01/2018
• Prospective Registration: Yes
• Primary sponsor: OPHTHOTECH CORPORATION
• Public title: A Clinical Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ in Subjects with Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
• Scientific title: 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
• Date of first enrolment: 09/03/2018
• Target sample size: 277
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003991-56
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: yes; Other specify the comparator: Zimura and sham administered by an unmasked investigator; Number of treatment arms in the trial: 6
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Croatia, Czech Republic, Estonia, Hungary, Israel, Latvia, United States

Contacts

• Name: Patricia Johnson
• Affiliation: OPHTHOTECH CORPORATION

• Name: Patricia Johnson
• Affiliation: OPHTHOTECH CORPORATION

Key inclusion & exclusion criteria

Inclusion criteria:
Ophthalmic Inclusion Criteria

The following inclusion criteria apply to the SE:

- Non-foveal GA secondary to dry AMD.

- The atrophic lesion must be able to be photographed in its entirety.

- Best corrected visual acuity in the SE between 20/25 – 20/320, inclusive.

General Inclusion Criteria

- Subjects of either gender aged =50 years.

- Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.

- Provide written informed consent.

- Ability to return for all trial visits.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 207

Exclusion criteria:
Exclusion Criteria
Subjects will not be eligible for the trial if subjects cannot attend all trial required visits, or if any of the following criteria are present systemically or in the SE:

Ophthalmic Exclusion Criteria
The following exclusion criteria apply to the SE:

- Evidence of CNV in either eye.

- Any prior treatment for AMD or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals.

- Presence of other causes of choroidal neovascularization.

- Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region, regardless of indication.

- Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks.

- Any sign of diabetic retinopathy in either eye.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
MedDRA version: 20.0 Level: PT Classification code 10075567 Term: Dry age-related macular degeneration System Organ Class: 10015919 - Eye disorders

Therapeutic area: Diseases [C] - Eye Diseases [C11]

Intervention(s)

Product Name: Zimura
Product Code: ARC1905
Pharmaceutical Form: Solution for injection
INN or Proposed INN: avacincaptad pegol
Current Sponsor code: Zimura
Other descriptive name: ARC1905
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): Primary Efficacy Endpoint:
Mean rate of change in GA over 12 months measured by FAF at three time points: Baseline, Month 6, and Month 12

Safety Endpoints:
- AEs
- Vital signs (pulse, systolic and diastolic blood pressure)
- Ophthalmic variables (IOP, ophthalmic examination, FA, FAF, and OCT)
- ECG (12-lead)
- Laboratory variables (blood: hematology, renal function, hepatic function, and electrolytes; urinalysis)

Timepoint(s) of evaluation of this end point: Primary Efficacy Endpoint: From Baseline to Month 12

Secondary Objective: Not Applicable

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: From Baseline to Month 12

Secondary end point(s): Secondary Efficacy Endpoints:
- The mean change in best corrected visual acuity (ETDRS letters) from Baseline to Month 12
- Mean change in low luminance best corrected visual acuity (ETDRS letters) from Baseline to Month 12

Secondary ID(s)

OPH2003

2015-003991-56-HU

Source(s) of Monetary Support

OPHTHOTECH CORPORATION

Ethics review

Status: Approved
Approval date: 10/01/2018
Contact: