A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Age-Related Macular Degeneration | Drug: E10030 plus Lucentis Drug: Lucentis | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Randomized, Double-Masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Injections of E10030 (Anti-PDGF Pegylated Aptamer) Given in Combination With Lucentis in Subjects With Neovascular Age-Related Macular Degeneration |
- Mean Change in Visual Acuity From Baseline at the Week 24 Visit [ Time Frame: 24 Weeks ]The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit
- The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit [ Time Frame: 24 weeks ]The proportion of subjects gaining 15 or more ETDRS letters from baseline at the Week 24 visit
- Proportion of Patients With at Least 1 Adverse Event [ Time Frame: 24 weeks ]
| Enrollment: | 449 |
| Study Start Date: | March 2010 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Lucentis |
Drug: Lucentis
10 mg/mL intravitreal injection monthly
|
| Experimental: E10030 low dose plus Lucentis |
Drug: E10030 plus Lucentis
once a month intravitreal injection
|
| Experimental: E10030 high dose plus Lucentis |
Drug: E10030 plus Lucentis
once a month intravitreal injection
|
Detailed Description:
Subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- E10030 0.3 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 1.5 mg/eye + Lucentis® 0. 5 mg/eye
- E10030 sham + Lucentis® 0. 5 mg/eye
Subjects will be treated with active E10030 or sham E10030 in combination with Lucentis® at Day 0, Week 4, Week 8, Week 12, Week 16 and Week 20.
Primary Efficacy Endpoint:
The primary efficacy endpoint is mean change in visual acuity from baseline at the Week 24 visit
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables [visual acuity, intraocular pressure (IOP), ophthalmic examination, color fundus photography, fluorescein angiograms (FA), optical coherence tomography (OCT)], and laboratory variables.
Approximately 444 subjects will be randomized into one of the three treatment cohorts (approximately 148 patients per dose group).
Eligibility
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| Ages Eligible for Study: | 50 Years to 100 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion Criteria:
Any of the following underlying diseases including:
- Diabetes mellitus
- 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 coronary artery revascularization within 6 months, or ventricular tachyarrhythmias requiring ongoing treatment.
- Clinically significant impaired renal or hepatic function.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry.
- Known serious allergies to the fluorescein dye used in angiography (mild allergy amenable to treatment is allowable), to the components of the ranibizumab (Lucentis) formulation, or to the components of the E10030 formulation
Contacts and Locations
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): NCT01089517
| United States, South Carolina | |
| Palmetto Retinal Center | |
| West Columbia, South Carolina, United States, 29169 | |
More Information
| Responsible Party: | Ophthotech Corporation |
| ClinicalTrials.gov Identifier: | NCT01089517 History of Changes |
| Other Study ID Numbers: |
OPH1001 |
| First Submitted: | March 12, 2010 |
| First Posted: | March 18, 2010 |
| Results First Submitted: | November 13, 2013 |
| Results First Posted: | January 3, 2014 |
| Last Update Posted: | May 12, 2017 |
| Last Verified: | April 2017 |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab Immunologic Factors |
Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |