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

Overview

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).

Full Title of Study: “A Phase I Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2012

Interventions

  • Drug: ARC1905
    • intravitreal injection

Arms, Groups and Cohorts

  • Active Comparator: dose comparison
  • Active Comparator: Dose comparison

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

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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