Last updated: February 20, 2024
Sponsor: Ophthotech Corporation
Overall Status: Completed
Phase
1
Condition
Aging
Myopic Macular Degeneration
Macular Degeneration
Treatment
E10030
Clinical Study ID
NCT00569140
OPH 1000
Ages 50-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion
Exclusion Criteria:
- Any of the following underlying diseases including:
- Diabetic retinopathy.
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III orIV - see Appendix 19.6), history or clinical evidence of unstable angina, acutecoronary syndrome, myocardial infarction or revascularization with 6 months,ventricular tachyarrythmias requiring ongoing treatment.
- History or evidence of clinically significant peripheral vascular disease, suchas intermittent claudication or prior amputation.
- Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renaltransplant or receiving dialysis) or hepatic function.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry. Previoustherapeutic radiation in the region of the study eye. Any treatment with aninvestigational agent in the past 60 days for any condition. Known serious allergies to the fluorescein dye used in angiography, to the components ofthe ranibizumab formulation, or to the components of the E10030 formulation.
Study Design
Total Participants: 18
Treatment Group(s): 1
Primary Treatment: E10030
Phase: 1
Study Start date:
December 01, 2007
Estimated Completion Date:
December 31, 2008
Connect with a study center
Denise Teuber
New York, New York 10119
United StatesSite Not Available

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