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Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair (PREVENT-PVR)

Primary Purpose

Retinal Detachment With Multiple Breaks, Unspecified Eye, Proliferative Vitreoretinopathy

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intravitreal aflibercept injection

Sham control

About this trial

This is an interventional prevention trial for Retinal Detachment With Multiple Breaks, Unspecified Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Wills Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Intervention (serial IAI)

Control

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Single surgery anatomic success (retinal re-attachment) rate

Secondary Outcome Measures

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.

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.

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

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

Visual acuity will be measured using a typical Snellen chart.

OCT-measured central subfield thickness

Automated or manual central subfield thickness will be measured using the optical coherence tomography software.

Full Information

NCT ID

NCT04580147

First Posted

September 16, 2020

Last Updated

May 2, 2022

Sponsor

M. Ali Khan, MD

Collaborators

Southeastern Retina Associates, Eye Associates of New Mexico, University of California, Los Angeles

1. Study Identification

Unique Protocol Identification Number

NCT04580147

Brief Title

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

Acronym

PREVENT-PVR

Official Title

A Multi-Center, Randomized, Sham-Controlled, Phase II Trial Evaluating Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Macula Off Rhegmatogenous Retinal Detachment Repair (The PREVENT-PVR Trial)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 15, 2020 (Actual)

Primary Completion Date

September 15, 2023 (Anticipated)

Study Completion Date

December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

M. Ali Khan, MD

Collaborators

Southeastern Retina Associates, Eye Associates of New Mexico, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Detachment With Multiple Breaks, Unspecified Eye, Proliferative Vitreoretinopathy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention (serial IAI)

Arm Type

Experimental

Arm Description

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)

Arm Title

Control

Arm Type

Sham Comparator

Arm Description

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)

Intervention Type

Drug

Intervention Name(s)

Intravitreal aflibercept injection

Other Intervention Name(s)

Intravitreal Eylea injection

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

Sham control

Intervention Description

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

Primary Outcome Measure Information:

Title

Single surgery anatomic success (retinal re-attachment) rate

Time Frame

4 months

Secondary Outcome Measure Information:

Title

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

Description

Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment.

Time Frame

4 months

Title

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

Description

Epiretinal membrane is defined as preretinal membrane overlying the macula.

Time Frame

4 months

Title

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

Description

PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold

Time Frame

4 months

Title

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

Description

Visual acuity will be measured using a typical Snellen chart.

Time Frame

4 months

Title

OCT-measured central subfield thickness

Description

Automated or manual central subfield thickness will be measured using the optical coherence tomography software.

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brianna Kenney

Phone

215-928-3092

research@midatlanticretina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed A Khan, M

Organizational Affiliation

Wills Eye Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wills Eye Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brianna Kenney

Phone

215-928-3092

research@midatlanticretina.com

First Name & Middle Initial & Last Name & Degree

Mohammed A Khan, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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