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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ophthotech Corporation
ClinicalTrials.gov Identifier:
NCT01089517
First received: March 12, 2010
Last updated: November 13, 2013
Last verified: November 2013
History of Changes
  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:

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
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

No publications provided

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
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on February 27, 2015