A Phase 2 interventional study of Intravitreal aflibercept injection and Sham control in Retinal Detachment With Multiple Breaks, Unspecified Eye and Proliferative Vitreoretinopathy, sponsored by M. Ali Khan, MD. Status unknown at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-03.
Sponsored by M. Ali Khan, MD · Phase 2, Interventional, and Prevention
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.
The objective of this study is to determine if serial intravitreal aflibercept injections (IAI) improve single surgery anatomic success rate and reduce development of clinically apparent proliferative vitreoretinopathy (PVR) following surgical repair of primary, macula involving rhegmatogenous retinal detachment (RRD).
This will be a randomized clinical trial, with participant enrollment lasting \~120 days. 150 eyes will be randomized 1:1 to intervention (serial IAI) versus sham control (standard of care). Adult eyes with macula involving primary RRD deemed at high risk for PVR development as determined by pre-specified clinical features are eligible for enrollment.
The study, Aflibercept group will receive intravitreal aflibercept injection (2mg/0.05mL) at the conclusion of RRD repair surgery, at post-operative day 30 (plus/minus 7 days), and at post-operative day 60 (plus/minus 7 days). Patients enrolled in the control group will undergo a sham procedure at post-operative day 30 (plus/minus 7 days) and at post-operative day 60 (plus/minus 7 days).
The primary outcome will be single surgery anatomic success (retinal re-attachment) rate. Additional outcomes will include: systemic and ocular safety of IAI in setting of RRD; epiretinal membrane formation; presence of grade C PVR or worse; post-operative complication profile; OCT-measured central macular thickness; change from baseline in visual acuity (Snellen) wearing habitual correction.
All eyes will undergo pars plana vitrectomy with or without scleral buckling and gas tamponade. Post-operative exams (slit lamp biomicroscopy and indirect ophthalmoscopy) will include the following time-points: Day 30, Day 60, Day 90, Day 120. All time points will have a window of plus/minus 7 days, except the Day 120 visit which will be a window of plus/minus 14 days.
39 studies on the registry are indexed under Vitreoretinopathy, Proliferative; 9 are open to participants now.
This study's planned enrollment of 150 is above the median of 61 across 28 interventional studies indexed under Vitreoretinopathy, Proliferative.
Browse Vitreoretinopathy, Proliferative studies →This is the only study on the registry with M. Ali Khan, MD as lead sponsor.
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Exclusion Criteria:
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
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
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
Sham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)
Single surgery anatomic success (retinal re-attachment) rate
Time frame: 4 months
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points
Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment.
Time frame: 4 months
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
Epiretinal membrane is defined as preretinal membrane overlying the macula.
Time frame: 4 months
The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination. Presence of grade C PVR or worse
PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold
Time frame: 4 months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Visual acuity will be measured using a typical Snellen chart.
Time frame: 4 months
OCT-measured central subfield thickness
Automated or manual central subfield thickness will be measured using the optical coherence tomography software.
Time frame: 4 months
Plan to share: No
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aflibercept
Vitreoretinopathy, Proliferative →