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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)

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Nonproliferative Diabetic Retinopathy Drug: Intravitreal aflibercept injection [IAI] Drug: Sham Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 29, 2016
Actual Primary Completion Date : August 6, 2018
Actual Study Completion Date : July 16, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dosing regimen 1
Participants will receive IVT aflibercept dosing regimen 1
 Drug: Intravitreal aflibercept injection [IAI]
Other Names:
  • EYLEA® (aflibercept) Injection
  • BAY86-5321
Experimental: Dosing regimen 2
Participants will receive IVT aflibercept dosing regimen 2
 Drug: Intravitreal aflibercept injection [IAI]
Other Names:
  • EYLEA® (aflibercept) Injection
  • BAY86-5321
Sham Comparator: Dosing regimen 3
Participants will receive matching sham injections
 Drug: Sham


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718326


Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Regeneron Pharmaceuticals:
Study Protocol  [PDF] July 24, 2018
Statistical Analysis Plan  [PDF] July 9, 2018

More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02718326    
Other Study ID Numbers: VGFTe-OD-1411
2016-002639-14 ( EudraCT Number )
First Posted: March 24, 2016    Key Record Dates
Results First Posted: November 21, 2019
Last Update Posted: July 30, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases