Retinal Detachment With Multiple Breaks, Unspecified EyePhase 2PREVENT-PVRNCT04580147
Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair
A Phase 2 study testing Intravitreal aflibercept injection in people with Retinal Detachment With Multiple Breaks, Unspecified Eye and Proliferative Vitreoretinopathy, run by M. Ali Khan, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Detachment With Multiple Breaks, Unspecified Eye, Proliferative Vitreoretinopathy
- What is being tested?
- Intravitreal aflibercept injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 15 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Brianna Kenney, 215-928-3092, research@midatlanticretina.com
Mohammed A Khan, MD
About this study
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)
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.
Read the 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.
- Being tested
- Intravitreal aflibercept injection, Sham control
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal aflibercept injectionDrug
Also called Intravitreal Eylea injection
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 controlOther
Sham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single surgery anatomic success (retinal re-attachment) rate
Measured: 4 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: 4 months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Visual acuity will be measured using a typical Snellen chart.
Measured: 4 months
OCT-measured central subfield thickness
Automated or manual central subfield thickness will be measured using the optical coherence tomography software.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start15 Oct 2020
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Detachment With Multiple Breaks, Unspecified EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M. Ali Khan, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Southeastern Retina Associates, Eye Associates of New Mexico, University of California, Los Angeles
- Responsible party
- Sponsor-investigator, M. Ali Khan, MD, Wills Eye
- Investigators
- Mohammed A Khan, M, Principal investigator, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580147
- Sponsor's protocol ID
- PREVENTPVR_V1
- Acronym
- PREVENT-PVR
- Status last verified
- May 2022
- First submitted
- 16 Sep 2020
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04580147
- Acronym / sponsor ID
- PREVENT-PVR / PREVENTPVR_V1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M. Ali Khan, MDUniversity, hospital or other
- Collaborators
- Southeastern Retina Associates, Eye Associates of New Mexico, University of California, Los Angeles
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (serial IAI) | Experimental | Drug: Intravitreal aflibercept injectionIntravitreal 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) |
| Control | Sham comparator | Other: Sham controlPatients 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal aflibercept injectionAlso: Intravitreal Eylea injectionIntravitreal 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 | Intervention (serial IAI) |
| Sham controlSham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days) | Other | Control |
Primary outcome
Single surgery anatomic success (retinal re-attachment) rate
Time frame: 4 months
5 secondary outcomes
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points
Time frame: 4 months
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
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
Time frame: 4 months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Time frame: 4 months
OCT-measured central subfield thickness
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammed A Khan, M principal investigator
Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal aflibercept injection in people with Retinal Detachment With Multiple Breaks, Unspecified Eye and Proliferative Vitreoretinopathy, run by M. Ali Khan, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brianna Kenney (215-928-3092, research@midatlanticretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single surgery anatomic success (retinal re-attachment) rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.