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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:8/25/2017
Start Date:July 2009
End Date:November 2012

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

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).


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.
We found this trial at
1
site
One Penn Plaza Suite 1924 New York, NY 10119 Pennsylvania Plaza
New York, New York 10119
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mi
from
New York, NY
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