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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT00950638
First received: July 30, 2009
Last updated: November 5, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:
  • 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
Study Completion Date: November 2012
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950638

Locations
United States, New York
Ophthotech
New York, New York, United States
Sponsors and Collaborators
Ophthotech Corporation
  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: November 5, 2013
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 July 10, 2014