Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection) (RE-VIEW)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01722045
First received: November 2, 2012
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

This is a phase 4, open-label, single arm, multicenter, clinical study in patients with neovascular AMD designed to evaluate the efficacy and safety of Intravitreal Aflibercept Injection (IAI) administered over 2 years , and to provide clinical information from the first year in the trial evaluating the adverse effects, if any, on the corneal endothelium following administration of IAI.


Condition Intervention Phase
Age - Related Macular Degeneration (AMD)
Drug: Intravitreal Aflibercept Injection (IAI)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of the Efficacy, Safety, and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Aflibercept Injection) in Patients With Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Change in ETDRS letter score [ Time Frame: Day 1 to Week 100 ] [ Designated as safety issue: No ]
    Change in ETDRS (Early Treatment Diabetic Retinopathy Study) letter score from visit 2/baseline (day 1) to visit 17 (week 100).


Secondary Outcome Measures:
  • Change in cell density [ Time Frame: Day 1 to Week 52 ] [ Designated as safety issue: No ]
    Change in corneal endothelial cell density (cells per mm2) from visit 2/baseline (day 1) to visit 10 (week 52) as assessed by specular microscopy

  • Proportion of patients who score as 'dry' on OCT [ Time Frame: At Week 52 and Week 100 ] [ Designated as safety issue: No ]
    Proportion of patients who score as 'dry' on OCT at visit 10 (week 52) and visit 17 (week 100).

  • Percentage of Participants Who Gained at Least 15 Letters in BCVA [ Time Frame: At Week 52 and Week 100 ] [ Designated as safety issue: No ]
    Proportion of patients who gain greater than or equal to 15 ETDRS letters at visit 10 (week 52) and visit 17 (week 100)


Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open label IAI Drug: Intravitreal Aflibercept Injection (IAI)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria include but are not limited to:

  1. Men or women great than or equal to 50 years of age with unilateral neovascular AMD
  2. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
  3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye
  4. The CNV area must be at least 50% of total lesion size
  5. Willing and able to comply with clinic visits and study-related procedures
  6. Provide signed informed consent
  7. Provide signed Health Insurance Portability andAccountability Act (HIPAA) authorization

Exclusion criteria include but are not limited to:

  1. Neovascular AMD in the fellow eye
  2. Corneal endothelial measures as judged by an independent reading center
  3. Any prior use of intraocular anti-VEGF treatment for neovascular AMD in either eye
  4. Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema
  5. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening
  6. History of cataract surgery, or other intraocular surgery in either eye, within 1 year of screening, or yttrium aluminum garnet (YAG) Capsulotomy within 3 months of screening
  7. Contact lens wear in either eye within 6 months of screening
  8. History of angle closure glaucoma in either eye
  9. Intraocular laser therapy including selective laser trabeculoplasty (SLT), YAG, prophylactic peripheral iridotomy (PI) in either eye within 1 year of screening, or YAG Capsulotomy within 3 months of screening
  10. History of cataract surgery requiring an anterior chamber intraocular lens implant at any time in either eye
  11. Any prior ocular trauma (blunt or penetrating) in either eye
  12. Embedded corneal foreign body in either eye
  13. Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
  14. Ocular media of insufficient quality to obtain fundus and OCT images in the study eye
  15. Any prior ocular inflammation/infection in either eye within 3 months of the screening visit
  16. Any prior use of amantadine
  17. Significant pre-retinal fibrosis involving the macula in the study eye (where, in the opinion of the investigator, the pre-retinal fibrosis is causing distortion or traction on the central macular region which may be limiting vision, or inducing retinal edema/thickening, beyond that due to underlying CNV)
  18. Intraocular pressure (IOP) greater than or equal to 30 mm Hg in the study eye at screening
  19. Uncontrolled diabetes mellitus (DM) (HbA1c ≥8)
  20. Current treatment with systemic anti-VEGF therapeutics at screening
  21. Known serious allergy to the fluorescein sodium for injection in angiography
  22. Participation in an investigational study within 30 days prior to the screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
  23. Positive serum hCG pregnancy test at the screening visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722045

  Show 49 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01722045     History of Changes
Other Study ID Numbers: VGFTe-AMD-1124
Study First Received: November 2, 2012
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 16, 2014