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 has been completed.
Sponsor:
Information provided by:
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT00569140
First received: December 4, 2007
Last updated: January 21, 2010
Last verified: January 2010

December 4, 2007
January 21, 2010
December 2007
Not Provided
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
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age-Related Macular Degeneration
Drug: E10030
Intravitreal injection
No Intervention: 1
E10030
Intervention: Drug: E10030
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
December 2008
Not Provided

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 information is only displayed when the study is recruiting subjects
United States
 
NCT00569140
OPH 1000
No
Denise Teuber, Ophthotech Corp
Ophthotech Corporation
Not Provided
Not Provided
Ophthotech Corporation
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP