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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 : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : May 22, 2018
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).

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
Estimated Primary Completion Date : August 6, 2018
Estimated Study Completion Date : August 14, 2019

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


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of participants who have improved by ≥2 steps from baseline on the Diabetic Retinopathy Severity Scale (DRSS) score at week 24 [ Time Frame: At week 24 ]
  2. Proportion of patients who have improved by ≥2 steps from baseline on the DRSS score at week 52 [ Time Frame: At week 52 ]

Secondary Outcome Measures :
  1. Proportion of participants developing a vision-threatening complication due to diabetic retinopathy through week 100 [ Time Frame: Baseline to week 100 ]
  2. Proportion of participants developing central-involved DME (CI-DME) through week 100 [ Time Frame: Baseline to week 100 ]
  3. Time to development of a vision-threatening complication through week 100 [ Time Frame: Baseline to week 100 ]
  4. Time to development of CI-DME through week 100 [ Time Frame: Baseline to week 100 ]
  5. Proportion of participants who receive panretinal photocoagulation (PRP) through week 100 [ Time Frame: Baseline to week 100 ]
  6. Area under the curve (AUC) for change in best corrected visual acuity (BCVA) from baseline at week 100 [ Time Frame: At week 100 ]

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 NPDR (DRSS levels 47 or 53), confirmed by the central reading center, in whom PRP can be safely deferred for at least 6 months per the investigator
  2. BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Key Exclusion Criteria:

  1. Presence of 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-VEGF treatment or 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
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


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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
More Information
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02718326     History of Changes
Other Study ID Numbers: VGFTe-OD-1411
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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