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

NCT04580147 | Unknown Phase 2 FDA Drug

• 1 other identifier: PREVENTPVR_V1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Single surgery anatomic success (retinal re-attachment) rate

  4 months

Secondary Outcomes (5)

• Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points

  4 months

• The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging

  4 months

• The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination. Presence of grade C PVR or worse

  4 months

• Change from baseline in visual acuity (Snellen) wearing habitual correction.

  4 months

• OCT-measured central subfield thickness

  4 months

Study Arms (2)

Intervention (serial IAI)

EXPERIMENTAL

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)

Drug: Intravitreal aflibercept injection

Control

SHAM COMPARATOR

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)

Other: Sham control

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)

Also known as: Intravitreal Eylea injection

Intervention (serial IAI)

Sham control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Carry a diagnosis of a macula involving ("macula off") primary RRD at high risk for PVR development. Specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (\>3); detachments involving two or more quadrants of the retina; duration of detachment \> 3 weeks; vitreous hemorrhage; and choroidal detachment.
• Consent to surgical repair utilizing pars plana vitrectomy with or without scleral buckling and C3F8 gas tamponade
• Willing and able to comply with clinic visits and study-related procedures
• Provide signed informed consent
• Able to understand and complete study-related questionnaires

You may not qualify if:

• Age \<18 years
• Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair
• Method of primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.
• Primary use of silicone oil or retinectomy during surgical repair (if silicone oil and/or a retinectomy is used intraoperatively, a prior enrolled patient will be disqualified from the study)
• Prior incisional ocular surgery other than cataract extraction
• History of or concurrent ruptured globe, intraocular foreign body, diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocular infectious disease
• Treatment with intravitreal or systemic anti-VEGF pharmacotherapy in the prior 6 months.
• Pregnant or breastfeeding women
• Sexually active women of childbearing potential\* who are unwilling to practice adequate contraception prior to start of the first treatment, during the study, and for at least 3 months after the last dose. Adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly.

Sponsors & Collaborators

• M. Ali Khan, MD: lead
• Southeastern Retina Associates: collaborator
• Eye Associates of New Mexico: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Mohammed A Khan, M

  Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brianna Kenney

CONTACT

215-928-3092; research@midatlanticretina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Retina Service

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 8, 2020
• Study Start: October 15, 2020
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: May 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)