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Trial record 1 of 1 for:    VGFTe-OD-1411
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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)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02718326
First Posted: March 24, 2016
Last Update Posted: August 25, 2017
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.
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
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 Intervention Phase
Nonproliferative Diabetic Retinopathy Drug: Intravitreal aflibercept injection [IAI] Drug: Sham Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 402
Study Start Date: April 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 86 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02718326     History of Changes
Other Study ID Numbers: VGFTe-OD-1411
First Submitted: March 20, 2016
First Posted: March 24, 2016
Last Update Posted: August 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases