ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
Primary Purpose
Age-Related Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARC1905
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD
Eligibility Criteria
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.
Sites / Locations
- Ophthotech Corp
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00709527
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARC1905
Intervention Description
intravitreal injection
Primary Outcome Measure Information:
Title
Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ophthotech Corp
City
New York
State/Province
New York
ZIP/Postal Code
10119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ARC1905 (ANTI-C5 APTAMER) Given Either In Combination Therapy With Lucentis® 0.5 mg/Eye In Subjects With Neovascular Age-Related Macular Degeneration
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