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

Purpose

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	Intervention	Phase
Age-Related Macular Degeneration	Drug: E10030 plus Lucentis Drug: Lucentis	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Further study details as provided by Ophthotech Corporation:

Primary Outcome Measures:

Mean Change in Visual Acuity From Baseline at the Week 24 Visit [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the mean change in visual acuity from baseline at the Week 24 visit

Secondary Outcome Measures:

The Proportion of Subjects Gaining 15 or More ETDRS Letters From Baseline at the Week 24 Visit [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]


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


Ages Eligible for Study:	50 Years and older (Adult, Senior)
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:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01089517

Locations


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

Sponsors and Collaborators

Ophthotech Corporation

More Information


Responsible Party:	Ophthotech Corporation
ClinicalTrials.gov Identifier:	NCT01089517 History of Changes
Other Study ID Numbers:	OPH1001
Study First Received:	March 12, 2010
Results First Received:	November 13, 2013
Last Updated:	November 13, 2013
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 23, 2016