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A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
This study is currently recruiting participants.
Study NCT00569140   Information provided by Ophthotech Corporation
First Received: December 4, 2007   Last Updated: January 9, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

December 4, 2007
January 9, 2009
December 2007
Ophthalmic DLTs [ Time Frame: immediate ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00569140 on ClinicalTrials.gov Archive Site
adverse events [ Time Frame: immendiate ] [ Designated as safety issue: Yes ]
Same as current
 
A Phase 1, Safety, Tolerability and Pharmacokinetic Profile of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) in Subjects With Neovascular Age-Related Macular Degeneration
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 Neovascular Age-Related Macular Degeneration

The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of E10030 intravitreous injection when administered as monotherapy or in combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

 
Phase I
Interventional
Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Age-Related Macular Degeneration
Drug: E10030
No Intervention: E10030
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
18
December 2009
 

Inclusion Criteria:

Subfoveal choroidal neovascularization (CNV) due to AMD

Exclusion Criteria:

  • Any of the following underlying diseases including:

    • Diabetic retinopathy.
    • History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 19.6), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 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.
    • 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.

Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the E10030 formulation.

Both
50 Years and older
No
Contact: Denise Teuber 212 845-8207 denise.teuber@ophthotech.com
United States
 
 
NCT00569140
Denise Teuber, Ophthotech Corp
 
Ophthotech Corporation
 
 
Ophthotech Corporation
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.