ARC1905 (Anti-C5 Aptamer) Given With Lucentis 0.5 mg In People With Neovascular Age-Related Macular Degeneration

NCT00709527 | Completed Phase 1

• 1 other identifier: OPH2000
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

AMD

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (1)

1

EXPERIMENTAL

Drug: Avacincaptad Pegol

Interventions

Avacincaptad Pegol DRUG

intravitreal injection

Also known as: Zimura (previous name), IZERVAY, ARC1905

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram.

You may not qualify if:

• Previous or concomitant therapy with intravitreous corticosteroids.
• 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 s/p renal transplant or receiving dialysis) or hepatic function. Patients 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, to the components of the ranibizumab formulation, or to the components of the ARC1905 formulation.

Sponsors & Collaborators

• Ophthotech Corporation: lead

Study Sites (1)

Ophthotech Corp

New York, New York, 10119, United States

Location

Related Links

• Link to plain language summary of the study on the Trial Results Summaries website

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: October 16, 2008
• Primary Completion: December 30, 2009
• Study Completion: December 30, 2009
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

US (1)