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
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ClinicalTrials.gov Identifier: NCT00569140 |
Recruitment Status :
Completed
First Posted : December 6, 2007
Last Update Posted : January 25, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Age-Related Macular Degeneration | Drug: E10030 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 18 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2007 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
No Intervention: 1
E10030
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Drug: E10030
Intravitreal injection |
- Ophthalmic DLTs [ Time Frame: immediate ]
- adverse events [ Time Frame: immendiate ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria:
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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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569140
United States, New York | |
Denise Teuber | |
New York, New York, United States, 10119 |
Responsible Party: | Denise Teuber, Ophthotech Corp |
ClinicalTrials.gov Identifier: | NCT00569140 |
Other Study ID Numbers: |
OPH 1000 |
First Posted: | December 6, 2007 Key Record Dates |
Last Update Posted: | January 25, 2010 |
Last Verified: | January 2010 |
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |