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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

This study has been completed.
Information provided by (Responsible Party):
Ophthotech Corporation Identifier:
First received: July 1, 2008
Last updated: June 14, 2012
Last verified: June 2012
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 Intervention Phase
Age-Related Macular Degeneration Drug: ARC1905 Phase 1

Study Type: Interventional
Study Design: 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

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: 2 years ]

Enrollment: 60
Study Start Date: July 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ARC1905
intravitreal injection


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00709527

United States, New York
Ophthotech Corp
New York, New York, United States, 10119
Sponsors and Collaborators
Ophthotech Corporation
  More Information

Responsible Party: Ophthotech Corporation Identifier: NCT00709527     History of Changes
Other Study ID Numbers: OPH2000
Study First Received: July 1, 2008
Last Updated: June 14, 2012

Keywords provided by Ophthotech Corporation:

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on September 21, 2017