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Trial record 1 of 1 for:    Panorama | Diabetic Retinopathy
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Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR) (PANORAMA)

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: NCT02718326
Recruitment Status : Completed
First Posted : March 24, 2016
Results First Posted : November 21, 2019
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 20, 2016
First Posted Date  ICMJE March 24, 2016
Results First Submitted Date  ICMJE August 6, 2019
Results First Posted Date  ICMJE November 21, 2019
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE March 29, 2016
Actual Primary Completion Date August 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups [ Time Frame: At Week 24 ]
    The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.
  • Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline [ Time Frame: At Week 52 ]
    The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Proportion of patients who have improved by ≥2 steps from baseline on the Diabetic Retinopathy Severity Scale (DRSS) score at week 24 [ Time Frame: Baseline to week 24 ]
  • Proportion of patients who have improved by ≥2 steps from baseline on the DRSS score at week 52 [ Time Frame: Baseline to week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 [ Time Frame: At Week 52 ]
    Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle).
  • Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52 [ Time Frame: At Week 52 ]
    The percentage of participants who developed CI-DME at week 52 were reported.
  • Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52 [ Time Frame: Baseline through week 52 (day 365) ]
    Vision-threatening complication (VTC) is defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris [at least 2 cumulative clock hours], and/or definitive neovascularization of the iridocorneal angle). Vision Threatening Complications include PDR/ASNV identified by investigators and Diabetic Retinopathy Scale Score (DRSS) >61.
  • Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52 [ Time Frame: Baseline through week 52 (day 365) ]
    Time to develop Central Involved-Diabetic Macular Edema (CI-DME) through week 52 reported.
  • Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52 [ Time Frame: At Week 52 ]
    The percentage of participants who received panretinal photocoagulation (PRP), inclusive of participants undergoing vitrectomy with endolaser, at week 52 were reported.
  • Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 [ Time Frame: At week 52 ]
    The area under the curve (AUC) is the area under the best corrected visual acuity (BCVA) versus time curve from baseline to week 52. Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Original Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • Proportion of patients developing a vision-threatening complication through week 100 [ Time Frame: Baseline to week 100 ]
  • Proportion of patients developing central-involved DME through week 100 [ Time Frame: Baseline to week 100 ]
  • Time to development of a vision-threatening complication through week 100 [ Time Frame: Baseline to week 100 ]
  • Time to development of central-involved DME through week 100 [ Time Frame: Baseline to week 100 ]
  • Proportion of patients who receive panretinal photocoagulation (PRP) through week 100 [ Time Frame: Baseline to week 100 ]
  • Area under the curve (AUC) for change in best corrected visual acuity (BCVA) from baseline at week 100 [ Time Frame: Baseline to week 100 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
Official Title  ICMJE A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
Brief Summary

The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).

The secondary objectives of the study are:

  • To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
  • To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
  • To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR
Detailed Description Not Provided
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 Nonproliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: Intravitreal aflibercept injection [IAI]
    Other Names:
    • EYLEA® (aflibercept) Injection
    • BAY86-5321
  • Drug: Sham
Study Arms  ICMJE
  • Experimental: Dosing regimen 1
    Participants will receive IVT aflibercept dosing regimen 1
    Intervention: Drug: Intravitreal aflibercept injection [IAI]
  • Experimental: Dosing regimen 2
    Participants will receive IVT aflibercept dosing regimen 2
    Intervention: Drug: Intravitreal aflibercept injection [IAI]
  • Sham Comparator: Dosing regimen 3
    Participants will receive matching sham injections
    Intervention: Drug: Sham
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2017)
402
Original Estimated Enrollment  ICMJE
 (submitted: March 23, 2016)
360
Actual Study Completion Date  ICMJE July 16, 2019
Actual Primary Completion Date August 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
  2. Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Key Exclusion Criteria:

  1. Presence of diabetic macular edema (DME) threatening the center of the macula in the study eye
  2. Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
  3. Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
  4. Any prior systemic anti-vascular endothelial growth factor (VEGF) treatment or intravitreal (IVT) anti-VEGF treatment in the study eye
  5. Any prior intraocular steroid injection in the study eye
  6. Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye

Note: Other inclusion/ exclusion criteria apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 Germany,   Hungary,   Japan,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02718326
Other Study ID Numbers  ICMJE VGFTe-OD-1411
2016-002639-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
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 July 2020

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