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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)

NCT ID: NCT02718326

Last Updated: 2020-07-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-29

Study Completion Date

2019-07-16

Brief Summary

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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

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Detailed Description

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Conditions

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Nonproliferative Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dosing regimen 1

Participants will receive IVT aflibercept dosing regimen 1

Group Type EXPERIMENTAL

Intravitreal aflibercept injection [IAI]

Intervention Type DRUG

Dosing regimen 2

Participants will receive IVT aflibercept dosing regimen 2

Group Type EXPERIMENTAL

Intravitreal aflibercept injection [IAI]

Intervention Type DRUG

Dosing regimen 3

Participants will receive matching sham injections

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

Interventions

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Intravitreal aflibercept injection [IAI]

Intervention Type DRUG

Sham

Intervention Type DRUG

Other Intervention Names

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EYLEA® (aflibercept) Injection BAY86-5321

Eligibility Criteria

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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)

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

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Regeneron Study Site

Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Arcadia, California, United States

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Beverly Hills, California, United States

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Encino, California, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Mountain View, California, United States

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Oakland, California, United States

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Oceanside, California, United States

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Sacramento, California, United States

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Colorado Springs, Colorado, United States

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Golden, Colorado, United States

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New London, Connecticut, United States

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Altamonte Springs, Florida, United States

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Deerfield Beach, Florida, United States

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Fort Myers, Florida, United States

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Lakeland, Florida, United States

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Largo, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Winter Haven, Florida, United States

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Marietta, Georgia, United States

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Tucker, Georgia, United States

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Chicago, Illinois, United States

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Oak Forest, Illinois, United States

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Indianapolis, Indiana, United States

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New Albany, Indiana, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Hagerstown, Maryland, United States

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Boston, Massachusetts, United States

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Henderson, Nevada, United States

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Bloomfield, New Jersey, United States

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Albuquerque, New Mexico, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Kingston, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Florence, South Carolina, United States

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Ladson, South Carolina, United States

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West Columbia, South Carolina, United States

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Rapid City, South Dakota, United States

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Chattanooga, Tennessee, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Abilene, Texas, United States

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Regeneron Study Site 1

Austin, Texas, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Harlingen, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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The Woodlands, Texas, United States

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Willow Park, Texas, United States

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Salt Lake City, Utah, United States

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Burlington, Vermont, United States

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Fairfax, Virginia, United States

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Spokane, Washington, United States

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Morgantown, West Virginia, United States

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Marburg, Hesse, Germany

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Münster, North Rhine-Westphalia, Germany

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Leipzig, Saxony, Germany

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Szeged, Csongrád megye, Hungary

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Debrecen, Hajdú-Bihar, Hungary

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Budapest, Pest County, Hungary

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Budapest, Pest County, Hungary

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Zalaegerszeg, Zala County, Hungary

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Asahikawa, Hokkaido, Japan

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Amagasaki, Hyōgo, Japan

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Matsumoto, Nagano, Japan

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Chiyoda City, Tokyo, Japan

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Kagoshima, , Japan

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Nagasaki, , Japan

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Arecibo, , Puerto Rico

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San Juan, , Puerto Rico

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Camberley, Surrey, United Kingdom

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Regeneron Study Site

London, , United Kingdom

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Countries

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United States Germany Hungary Japan Puerto Rico United Kingdom

References

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Brown DM, Wykoff CC, Boyer D, Heier JS, Clark WL, Emanuelli A, Higgins PM, Singer M, Weinreich DM, Yancopoulos GD, Berliner AJ, Chu K, Reed K, Cheng Y, Vitti R. Evaluation of Intravitreal Aflibercept for the Treatment of Severe Nonproliferative Diabetic Retinopathy: Results From the PANORAMA Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):946-955. doi: 10.1001/jamaophthalmol.2021.2809.

Reference Type DERIVED
PMID: 34351414 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-002639-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

VGFTe-OD-1411

Identifier Type: -

Identifier Source: org_study_id

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