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Study of Intravitreal REGN2176-3 in Participants 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
Results First Posted : October 26, 2020
Last Update Posted : October 26, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 13, 2015
First Posted Date  ICMJE April 16, 2015
Results First Submitted Date  ICMJE September 1, 2020
Results First Posted Date  ICMJE October 26, 2020
Last Update Posted Date October 26, 2020
Actual Study Start Date  ICMJE May 5, 2015
Actual Primary Completion Date August 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12 [ Time Frame: Baseline, Week 12 ]
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2020)
  • Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Week 12 ]
    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.
  • Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT) [ Time Frame: Week 12 ]
    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation.
  • Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA) [ Time Frame: Baseline, Week 12 ]
    The anatomical state of the retinal vasculature of the study eye and the fellow eye was evaluated by funduscopic examination, fundus photography and FA to evaluate the total lesion area, CNV area, classic CNV area, and fluorescein leakage. CNV area values measured in square millimeters, each disc area was equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes.
  • Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA) [ Time Frame: Baseline, Week 12 ]
    Total Lesion Size was assessed by Fluorescein Angiography.
  • Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS) [ Time Frame: Week 12 ]
    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at Week 12 compared with baseline.
  • Percent Change From Baseline in Subretinal Hyperreflectivity Material (SHM) at Week 12 Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Week 12 ]
    SHM was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement.
  • Change From Baseline in Central Retinal/Lesion Thickness at Week 12 Measured by Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Week 12 ]
    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.
Original 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
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 Participants 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 was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

  • To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
  • To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
  • To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD
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: REGN2176-3 (1 mg: 2 mg)
    Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
    Intervention: Drug: REGN2176-3
  • Experimental: REGN2176-3 (3 mg: 2 mg)
    Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
    Intervention: Drug: REGN2176-3
  • Experimental: Intravitreal Aflibercept Injection (IAI) 2 mg
    IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
    Intervention: Drug: Intravitreal Aflibercept Injection (IAI)
  • Experimental: REGN2176-3 (3 mg: 2 mg) to IAI 2 mg
    Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.
    Intervention: Drug: Intravitreal Aflibercept Injection (IAI)
  • Experimental: IAI 2 mg to REGN2176-3 (3 mg:2 mg)
    IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
    Intervention: Drug: REGN2176-3
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
Actual Study Completion Date  ICMJE April 3, 2017
Actual Primary Completion Date August 17, 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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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 October 2020

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