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ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration

Sponsor
Ophthotech Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT00709527
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
32
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Ascending Dose And Parallel Group Trial To Establish The Safety, Tolerability AND Pharmacokinetic Profile Of Multiple Intravitreous Injections Of ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Multiple Doses Of Lucentis® 0.5 mg/Eye, Or With One Induction Dose Of Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: ARC1905
intravitreal injection

Outcome Measures

Primary Outcome Measures

  1. Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram.
Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ophthotech Corp New York New York United States 10119

Sponsors and Collaborators

  • Ophthotech Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT00709527
Other Study ID Numbers:
  • OPH2000
First Posted:
Jul 3, 2008
Last Update Posted:
Jun 18, 2012
Last Verified:
Jun 1, 2012
Keywords provided by Ophthotech Corporation
AMD
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Jun 18, 2012