Proliferative Vitreoretinopathy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGIsotretinoin
Isotretinoin 20mg daily for 12 weeks
Sponsors
Wills Eye
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-70 year-old men or 50-70 year-old, post-menopausal women. * Healthy enough to participate in the study. * Willing and able to consent to participation. * Recurrent PVR-associated RD occurring at least 2 weeks after RD repair or * Primary RD (retinal detachment) associated with one or more high-risk features
Exclusion criteria
* History of hypersensitivity to isotretinoin. * Current use of a corticosteroid (excluding topical). * Any history of depression, anorexia, liver or pancreatic disease. * More than one prior surgical RD repair. * Patients with closed funnel retinal detachments. * Patients with chronic retinal detachment, defined as longer than 12 weeks. * Any use an oral retinoid within 6 months. * Systemic chemotherapy within 6 months. * Patients taking supplemental vitamin A. * Corneal opacity sufficient to impair surgical view. * Proliferative diabetic retinopathy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Retinal Attachment | 3 months | We will evaluate all patients for retinal attachment at 3 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Primary, High-risk Retinal Detachment Isotretinoin: Isotretinoin 20mg daily for 12 weeks | 58 |
| Recurrent RD Associated With PVR Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy
Isotretinoin: Isotretinoin 20mg daily for 12 weeks | 51 |
| Total | 109 |
Baseline characteristics
| Characteristic | Recurrent RD Associated With PVR | Primary, High-risk Retinal Detachment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 7 Participants | 23 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 51 Participants | 86 Participants |
| Age, Continuous | 59.7 years STANDARD_DEVIATION 11.8 | 56.8 years STANDARD_DEVIATION 10 | 57.1 years STANDARD_DEVIATION 10.3 |
| Region of Enrollment United States | 51 participants | 58 participants | 109 participants |
| Sex: Female, Male Female | 11 Participants | 15 Participants | 26 Participants |
| Sex: Female, Male Male | 40 Participants | 43 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 58 | 0 / 54 |
| serious Total, serious adverse events | 0 / 58 | 0 / 54 |
Outcome results
Primary
Rate of Retinal Attachment
We will evaluate all patients for retinal attachment at 3 months.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary, High-risk Retinal Detachment | Rate of Retinal Attachment | 50 Participants |
| Recurrent RD Associated With PVR | Rate of Retinal Attachment | 42 Participants |