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.

Sponsor:

Information provided by (Responsible Party):

Ophthotech Corporation

ClinicalTrials.gov Identifier:

NCT00709527

First received: July 1, 2008

Last updated: June 14, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2008
Last Updated Date	June 14, 2012
Start Date ^ICMJE	July 2008
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 2, 2008)	Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00709527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Official Title ^ICMJE	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
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).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Age-Related Macular Degeneration
Intervention ^ICMJE	Drug: ARC1905 intravitreal injection
Study Arm (s)	Experimental: 1 Intervention: Drug: ARC1905
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	60
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00709527
Other Study ID Numbers ^ICMJE	OPH2000
Has Data Monitoring Committee	Not Provided
Responsible Party	Ophthotech Corporation
Study Sponsor ^ICMJE	Ophthotech Corporation
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ophthotech Corporation
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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