A Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration

Phase 1

Completed

• Conditions: Dry Age-Related Macular Degeneration
• Interventions: Drug: Avacincaptad Pegol

• Registration Number: NCT00950638
• Lead Sponsor: Ophthotech Corporation

Brief Summary

The objectives of this study are to evaluate the safety and tolerability of ARC1905 intravitreous injection in subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-16
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-31
• Study First Posted: 2009-08-03
• Primary Completion: 2011-03-24
• Study Completion: 2011-03-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Dry AMD (drusen and/or geographic atrophy) in both eyes

Exclusion Criteria

• 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 (including blepharitis), or ocular surface inflammation in the past twelve (12) weeks.

History of any of the following procedures: Posterior vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant or retinal detachment.

Any of the following underlying diseases including:

• Diabetic retinopathy
• History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV ), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment.
• History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
• Clinically significant impaired renal (serum creatinine >2.5 mg/dl or status post renal transplant or receiving dialysis) or hepatic function. Subjects with results outside these ranges may be enrolled in consultation with Ophthotech.
• Stroke (within 12 months of trial entry).
• Any major surgical procedure within one month of trial entry. Previous therapeutic radiation in the region of the study eye. Any treatment with an investigational agent in the past 60 days for any condition.

Women who are pregnant or nursing. Known serious allergies to the fluorescein dye used in angiography or to the components of the ARC1905 formulation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dose comparison	Avacincaptad Pegol	-
Dose comparison	Avacincaptad Pegol	-

Primary Outcome Measures

Name	Time	Method
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes	1 year

Trial Locations

Locations (1)

Ophthotech; 🇺🇸 New York, New York, United States