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

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ClinicalTrials.gov Identifier: NCT02418754
Recruitment Status : Terminated (No additional efficacy seen with REGN2176-3 over aflibercept alone)
First Posted : April 16, 2015
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 16, 2015
Last Update Posted Date February 20, 2017
Study Start Date  ICMJE April 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
Change in Best corrected visual acuity (BCVA) [ Time Frame: Baseline at week 12 ]
The primary endpoint in the study is the change in BCVA at week 12.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02418754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2015)
  • Change in central retinal lesion thickness as measured by 0ptical coherence tomography (OCT) [ Time Frame: Baseline at week 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Incidence and severity of TEAEs through week 12
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Intravitreal REGN2176-3 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-Related Macular Degeneration
Intervention  ICMJE
  • Drug: REGN2176-3
  • Drug: Intravitreal Aflibercept Injection (IAI)
    Other Name: Eylea®
Study Arms  ICMJE
  • Experimental: Group 1
    Group 1 will receive REGN2176-3 dosing regimen 1
    Intervention: Drug: REGN2176-3
  • Experimental: Group 2
    Group 2 will receive REGN2176-3 dosing regimen 2
    Intervention: Drug: REGN2176-3
  • Experimental: Group 3
    Group 3 will receive Intravitreal Aflibercept Injection (IAI) monotherapy
    Intervention: Drug: Intravitreal Aflibercept Injection (IAI)
Publications * Not Provided

*   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: August 19, 2016)
505
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2015)
500
Estimated Study Completion Date  ICMJE June 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 treatment 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
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 Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02418754
Other Study ID Numbers  ICMJE R2176-3-AMD-1417
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date February 2017

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