A Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration
Recruitment status was Active, not recruiting
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Age-Related Macular Degeneration |
Drug: ARC1905 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of ARC1905 (Anti-C5 Aptamer) in Subjects With Dry Age-related Macular Degeneration |
- Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: dose comparison |
Drug: ARC1905
intravitreal injection
|
| Active Comparator: Dose comparison |
Drug: ARC1905
intravitreal injection
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Ophthotech Corporation |
| ClinicalTrials.gov Identifier: | NCT00950638 History of Changes |
| Other Study ID Numbers: | OPH2001 |
| Study First Received: | July 30, 2009 |
| Last Updated: | September 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ophthotech Corporation:
|
AMD |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 21, 2013