Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of Prematurity

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04101721
Phase
PHASE3
Status
Completed

Conditions

  • Retinopathy of Prematurity

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — DRUG
    Administered IVT
  • laser photocoagulation — PROCEDURE
    Transpupillary conventional laser will be administered according to standard local procedures.

Study Details

The primary objective of the study is to assess the efficacy of aflibercept compared to laser in patients diagnosed with retinopathy of prematurity (ROP). The secondary objectives of the study are to assess the need for a second treatment modality, to assess the recurrence of ROP in the study and to assess the safety and tolerability of aflibercept.

Key Dates

Start date
Oct 30, 2019
Status verified
Jul 2023
Primary completion
Aug 18, 2022
Completion
Aug 18, 2022

Study Design

Enrollment
127 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Aflibercept Group
    Patients will receive a single intravitreal (IVT) injection per eligible eye at baseline.
  • Experimental: Laser Group
    Patients will undergo laser treatment in each eligible eye at baseline.

Primary Outcome Measure

Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age [ Time Frame: Baseline to week 52 of chronological age ]

Locations (27)

FacilityCityStateZIPSite coordinators
Regeneron Study SitePhoenixArizona85016-
Regeneron Study SiteLa JollaCalifornia92093-
Regeneron Study SiteLoma LindaCalifornia92354-
Regeneron Study SiteOrangeCalifornia92868-
Regeneron Study SitePalo AltoCalifornia94303-
Regeneron Study SiteSan DiegoCalifornia92123-
Regeneron Study SiteSan FranciscoCalifornia94143-
Regeneron Study SiteGainesvilleFlorida32608-
Regeneron Study SiteAugustaGeorgia78705-
Regeneron Study SiteChicagoIllinois60612-
Regeneron Study SiteBostonMassachusetts02111-
Regeneron Study SiteAnn ArborMichigan48105-
Regeneron Study SiteRoyal OakMichigan48073-
Regeneron Study SiteBrooklynNew York11203-
Regeneron Study SiteBrooklynNew York11213-
Regeneron Study SiteBuffaloNew York14209-
Regeneron Study SiteNew YorkNew York10017-
Regeneron Study SiteNew YorkNew York10029-
Regeneron Study SiteThe BronxNew York10462-
Regeneron Study SiteValhallaNew York10595-
Regeneron Study SiteClevelandOhio44106-
Regeneron Study SiteOklahoma CityOklahoma73104-
Regeneron Study SiteProvidenceRhode Island02905-
Regeneron Study SiteAustinTexas78705-
Regeneron Study SiteSan AntonioTexas78229-
Regeneron Study SiteSan AntonioTexas78240-
Regeneron Study SiteMorgantownWest Virginia26506-

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Regeneron Study Site· Phoenix, AZRegeneron Study Site· La Jolla, CARegeneron Study Site· Loma Linda, CARegeneron Study Site· Orange, CARegeneron Study Site· Palo Alto, CARegeneron Study Site· San Diego, CA

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