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

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950638
• Other study ID #: OPH2001
• Status: Completed
• Phase: Phase 1
• Start date: July 2009
• Est. completion date: November 2012

Study information

• Verified date: August 2017
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• ARC1905
intravitreal injection

Locations

Country	Name	City	State
United States	Ophthotech	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Ophthotech Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes		1 year