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Study Detail: Ophthotech
Trial Description:
Summary
: A 12 week study of the study drug E100030 used in combination with Lucentis® for treatment of wet macular degeneration.
Basic Trial Information
|
Phase |
Disease |
Status |
Age |
Sponsor |
Protocol # |
|
1 |
CNV from AMD |
Recruiting |
≥ 50 yr |
Ophthotech |
OPH1000 |
Study Duration: 12 weeks
Eligibility Criteria:
Inclusion Criteria-
·
Classic, Minimally classic, or Occult Subfoveal CNV secondary to AMD.·
For patients with Minimally Classic or Occult CNV, must have documented vision loss of 2 or more lines of vision in the past 12 weeks OR the presence of blood OR an increase in size of lesion of 10% in the past 12 weeks·
Total area of the lesion must be ≤ 4 DA and must be at least 50% active CNV·
Visual Acuity (best corrected) of 20/80- 20/160 in the study eye. No restrictions in the Fellow Eye
Exclusion Criteria
·
Must be treatment naïve·
Lesion must not be comprised of more than 25% atrophy- no Subfoveal atrophy·
No intraocular surgery in the past 3 months·
No previous vitrectomy, pervious filtering surgery or the placement of a glaucoma drainage device·
No diabetes·
No severe cardiac disease·
No peripheral vascular disease·
No stroke within the past 12 months·
No significant kidney disease
Study Title :
A Phase 1, Single Ascending Dose Trial to Establish the Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Monotherapy and of E10030 given in combination with Lucentis® 0.5 mg/eye in Subjects with Neovbascular Age-Related Macular Degeneration.
Trial Contact Information
|
Site |
Study Coordinator |
|
Beachwood |
Diane W. 216/831-5704 ext. 6800 |