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

• Status: Recruiting
• Trial end date: 2021-09-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M. Ali Khan, MD
• Collaborators: Eye Associates of New Mexico; Southeastern Retina Associates; University of California, Los Angeles
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

1. 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.

2. Consent to surgical repair utilizing pars plana vitrectomy with or without scleral buckling and C3F8 gas tamponade

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

5. Able to understand and complete study-related questionnaires

Exclusion Criteria:

1. Age <18 years

2. Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair

3. Method of primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.

4. 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)

5. Prior incisional ocular surgery other than cataract extraction

6. 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

7. Treatment with intravitreal or systemic anti-VEGF pharmacotherapy in the prior 6 months.

8. Pregnant or breastfeeding women

9. 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.