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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
M. Ali Khan, MD
Study ID
NCT04580147
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Intravitreal aflibercept injection — DRUG
    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)
  • Sham control — OTHER
    Sham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)

Study Details

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.

Key Dates

Start date
Oct 15, 2020
Status verified
May 2022
Primary completion
Sep 15, 2023
Completion
Dec 15, 2023

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention (serial IAI)
    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)
  • Sham Comparator: Control
    Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 (+/-7 days) and at post-operative day 60 (+/-7 days)

Primary Outcome Measure

Single surgery anatomic success (retinal re-attachment) rate [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye HospitalPhiladelphiaPennsylvania19107
Brianna Kenney
[email protected]
215-928-3092
Mohammed A Khan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Philadelphia, PA

By research site
Wills Eye Hospital· Philadelphia, PA

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