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

March 12, 2010
November 13, 2013
March 2010
June 2012   (final data collection date for primary outcome measure)
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
15 letters gained [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the proportion of subjects gaining at least 15 letters between baseline and the Week 12 visit
Complete list of historical versions of study NCT01089517 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in visual acuity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • The mean change in visual acuity from baseline at Week 12
  • Change in area of choroidal neovascularization (CNV) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    • The mean change in area of choroidal neovascularization from baseline at Week 12 (by fluorescein angiogram)
  • Change in retinal thickness [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    • The mean change in central subfield retinal thickness from baseline at Week 12
  • Number of patients with Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
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

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).

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).

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related Macular Degeneration
  • Drug: E10030 plus Lucentis
    once a month intravitreal injection
  • Drug: Lucentis
    10 mg/mL intravitreal injection monthly
  • Active Comparator: Lucentis
    Intervention: Drug: Lucentis
  • Experimental: E10030 low dose plus Lucentis
    Intervention: Drug: E10030 plus Lucentis
  • Experimental: E10030 high dose plus Lucentis
    Intervention: Drug: E10030 plus Lucentis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
449
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01089517
OPH1001
No
Ophthotech Corporation
Ophthotech Corporation
Not Provided
Not Provided
Ophthotech Corporation
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP