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Study of Intravitreal REGN2176-3 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02418754
First received: April 13, 2015
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

The primary objective of the study is to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.


Condition Intervention Phase
Neovascular Age-Related Macular Degeneration
Drug: REGN2176-3
Drug: Intravitreal Aflibercept Injection (IAI)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 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 Best corrected visual acuity (BCVA) [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    The primary endpoint in the study is the change in BCVA at week 12.


Secondary Outcome Measures:
  • Change in central retinal lesion thickness as measured by 0ptical coherence tomography (OCT) [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Change in central retinal lesion thickness from baseline at week 12, as measured by 0ptical coherence tomography (OCT)

  • Proportion of patients with complete resolution of intraretinal and subretinal fluid as measured by OCT [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Proportion of patients with complete resolution of intraretinal and subretinal fluid from baseline at week 12, as measured by OCT

  • Change in choroidal neovascularization (CNV) area as measured by Fluorescein angiography (FA) [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Change in CNV area from baseline at week 12, as measured by Fluorescein angiography (FA)

  • Change in lesion size as measured by Optical coherence tomography (OCT) [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Change in lesion size from baseline at week 12, as measured by Optical coherence tomography (OCT)

  • Proportion of patients who gain ≥15 letters in BCVA as measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS) [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Proportion of patients who gain ≥15 letters in BCVA from baseline at week 12, as measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)

  • Change in subretinal hyperreflectivity material (SHM) as measured by OCT [ Time Frame: Baseline at week 12 ] [ Designated as safety issue: No ]
    Change in SHM from baseline at week 12, as measured by OCT

  • Incidence of Treatment-emergent adverse event (TEAEs) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: Yes ]
    Incidence and severity of TEAEs through week 12


Estimated Enrollment: 500
Study Start Date: April 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Group 1 will receive REGN2176-3 dosing regimen 1
Drug: REGN2176-3
Experimental: Group 2
Group 2 will receive REGN2176-3 dosing regimen 2
Drug: REGN2176-3
Experimental: Group 3
Group 3 will receive Intravitreal Aflibercept Injection (IAI) monotherapy
Drug: Intravitreal Aflibercept Injection (IAI)
Other Name: Eylea®

  Eligibility

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

Key Inclusion Criteria:

  1. Men or women ≥50 years of age
  2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
  3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
  4. Provide signed informed consent

Key Exclusion Criteria:

  1. Any prior treatment with anti-VEGF inhibitors in the study eye
  2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
  3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
  4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
  5. Prior vitrectomy in the study eye
  6. Any history of macular hole of stage 2 and above in the study eye
  7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
  8. History of corneal transplant in the study eye
  9. Evidence of diabetic retinopathy or diabetic macular edema in either eye
  10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit
  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: NCT02418754

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

  Show 84 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: NCT02418754     History of Changes
Other Study ID Numbers: R2176-3-AMD-1417
Study First Received: April 13, 2015
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on June 29, 2015