A Phase 4 interventional study of Isotretinoin in Proliferative Vitreoretinopathy, sponsored by Wills Eye. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-01.
Sponsored by Wills Eye · Phase 4, Interventional, and Prevention
Proliferative vitreoretinopathy (PVR), or secondary scarring on and around the retina, is an important cause of retinal re-detachment. The purpose of this study is to evaluate the effect of oral isotretinoin, which inhibits the growth of cells responsible for proliferative vitreoretinopathy (PVR), on recurrent retinal detachment.
Small retrospective studies have shown isotretinoin to be effective in reducing the rate of recurrent retinal detachment in patients with or at high risk for developing PVR. This is a prospective study to evaluate a low dose of oral isotretinoin in this regard. There are two arms to the study: 1) eyes with recurrent retinal detachment due to existing PVR, and 2) eyes with primary detachment and features associated with a high risk of PVR formation. Eligible and willing patients will receive a 12-week course of isotretinoin, and will be followed for retinal attachment rate, and PVR and/or ERM (epiretinal membrane) formation.
35 studies on the registry are indexed under Vitreoretinopathy, Proliferative; 9 are open to participants now.
This study's enrollment of 109 is above the median of 60 across 25 interventional studies indexed under Vitreoretinopathy, Proliferative.
Browse Vitreoretinopathy, Proliferative studies →Wills Eye is the lead sponsor of 74 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Drug: Isotretinoin
Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Drug: Isotretinoin
Isotretinoin 20mg daily for 12 weeks
Rate of Retinal Attachment
We will evaluate all patients for retinal attachment at 3 months.
Time frame: 3 months
| Milestone | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR |
|---|---|---|
| Started | 58 | 54 |
| Completed | 58 | 51 |
| Not completed | 0 | 3 |
We will evaluate all patients for retinal attachment at 3 months.
| Participants | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR |
|---|---|---|
| Rate of Retinal Attachment | 50 | 42 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Primary, High-risk Retinal Detachment | — | 0/58 (0%) | 0/58 (0%) |
| Recurrent RD Associated With PVR | — | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 51 | 35 | 86 |
| >=65 years | 7 | 16 | 23 |
| Age, Continuous(years) | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR | Total |
|---|---|---|---|
| Mean | 56.8 ± 10.0 | 59.7 ± 11.8 | 57.1 ± 10.3 |
| Sex: Female, Male(Participants) | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR | Total |
|---|---|---|---|
| Female | 15 | 11 | 26 |
| Male | 43 | 40 | 83 |
| Region of Enrollment(participants) | Primary, High-risk Retinal Detachment | Recurrent RD Associated With PVR | Total |
|---|---|---|---|
| United States | 58 | 51 | 109 |
Plan to share: No
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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Vitreoretinopathy, Proliferative→
Wills Eye