Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01944839
Recruitment Status : Terminated
First Posted : September 18, 2013
Results First Posted : August 10, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ophthotech ( Ophthotech Corporation )

Tracking Information
First Submitted Date  ICMJE September 9, 2013
First Posted Date  ICMJE September 18, 2013
Results First Submitted Date  ICMJE July 11, 2018
Results First Posted Date  ICMJE August 10, 2018
Last Update Posted Date August 10, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
Mean Change in Visual Acuity From Baseline to 12 Months [ Time Frame: 12 Months ]
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Mean Change in Visual Acuity from Baseline at the Month 12 Visit [ Time Frame: 12 Months ]
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Official Title  ICMJE A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Brief Summary The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Detailed Description

Subjects will be randomized in a 1:1 ratio to the following dose groups:

  • Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
  • Fovista® sham + Lucentis® 0.5 mg/eye

Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.

Primary Efficacy Endpoint:

The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.

Safety Endpoints:

Safety endpoints include adverse events, vital signs, ophthalmic variables [ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)], ECG, and laboratory variables.

Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: E10030
    Other Name: Fovista®
  • Drug: ranibizumab
    Other Name: Lucentis®
  • Drug: E10030 sham intravitreal injection
    Pressure on the eye with a syringe with no needle
    Other Name: Sham
Study Arms  ICMJE
  • Experimental: E10030 + ranibizumab
    E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
    Interventions:
    • Drug: E10030
    • Drug: ranibizumab
  • Active Comparator: Sham + ranibizumab
    E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
    Interventions:
    • Drug: ranibizumab
    • Drug: E10030 sham intravitreal injection
Publications * Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 13, 2016)
619
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
622
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects of either gender aged ≥ 50 years
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Presence of sub-retinal hyper-reflective material (SD-OCT)

Exclusion Criteria:

  • Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
  • Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
  • Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
  • Subjects with subfoveal scar or subfoveal atrophy are excluded
  • Diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Brazil,   Canada,   Czechia,   Estonia,   Italy,   Latvia,   Poland,   Slovakia,   Switzerland,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01944839
Other Study ID Numbers  ICMJE OPH1002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data at this time
Responsible Party Ophthotech ( Ophthotech Corporation )
Study Sponsor  ICMJE Ophthotech Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ophthotech
Verification Date August 2018

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