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.

Verified by Ophthotech Corporation, January 2009

Sponsored by:	Ophthotech Corporation
Information provided by:	Ophthotech Corporation
ClinicalTrials.gov Identifier:	NCT00569140

Purpose

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).

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: E10030	Phase I

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official 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 Neovascular Age-Related Macular Degeneration

Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:

Ophthalmic DLTs [ Time Frame: immediate ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

adverse events [ Time Frame: immendiate ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: No Intervention E10030	Drug: E10030 Intravitreal injection

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569140

Contacts

Contact: Denise Teuber

212 845-8207

denise.teuber@ophthotech.com

Locations

United States, New York
Denise Teuber	Recruiting
New York, New York, United States, 10119

Sponsors and Collaborators

Ophthotech Corporation

More Information

Responsible Party:	Ophthotech Corp ( Denise Teuber )
Study ID Numbers:	OPH 1000
Study First Received:	December 4, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00569140
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 15, 2009