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Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair

NCT04580147 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-05-03

No results posted yet for this study

Summary

The primary objective of the study is to determine if serial intravitreal aflibercept injections (IAI) improve the single surgery anatomic success rate following surgical repair of primary, macula involving rhegmatogenous retinal detachment (RRD) deemed at high risk for proliferative vitreoretinopathy (PVR). Preclinical work has revealed that competitive inhibition of platelet derived growth factor (PDGF) by vascular endothelial growth factor (VEGF) potentiates a pathologic, sustained activation of PDGF receptors that is critical to the progression of experimental PVR. VEGF blockade would mitigate this pathologic activation.

Conditions

  • Retinal Detachment With Multiple Breaks, Unspecified Eye
  • Proliferative Vitreoretinopathy

Interventions

DRUG

Intravitreal aflibercept injection

Intravitreal aflibercept injection (2mg/0.05mL) at the conclusion of RRD repair surgery, at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)

OTHER

Sham control

Sham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)

Sponsors & Collaborators

  • Southeastern Retina Associates

    collaborator UNKNOWN

  • Eye Associates of New Mexico

    collaborator UNKNOWN

  • University of California, Los Angeles

    collaborator OTHER

  • M. Ali Khan, MD

    lead OTHER

Principal Investigators

  • Mohammed A Khan, M · Wills Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-15
Primary Completion
2023-09-15
Completion
2023-12-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04580147 on ClinicalTrials.gov