A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration

Study Description

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Brief Summary:

The objectives of this study are to evaluate the safety and efficacy of E10030 intravitreous injection when administered in combination with Lucentis® against a control of Lucentis® alone in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Condition or disease	Intervention/treatment	Phase
Age-Related Macular Degeneration	Drug: E10030 plus Lucentis; Drug: Lucentis	Phase 2

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).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	449 participants
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
Study Start Date :	March 2010
Actual Primary Completion Date :	June 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. Proportion of Patients With at Least 1 Adverse Event [ Time Frame: 24 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years to 100 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, South Carolina
Palmetto Retinal Center
West Columbia, South Carolina, United States, 29169

Sponsors and Collaborators

Ophthotech Corporation

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ophthotech Corporation
ClinicalTrials.gov Identifier:	NCT01089517 History of Changes
Other Study ID Numbers:	OPH1001
First Posted:	March 18, 2010
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