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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary, high-risk retinal detachment | Experimental | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy |
|
| Recurrent RD associated with PVR | Experimental | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isotretinoin | Drug | Isotretinoin 20mg daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Retinal Attachment | We will evaluate all patients for retinal attachment at 3 months. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard S Kaiser, MD | Wills Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Primary, High-risk Retinal Detachment | Isotretinoin: Isotretinoin 20mg daily for 12 weeks |
| FG001 | Recurrent RD Associated With PVR | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy Isotretinoin: Isotretinoin 20mg daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary, High-risk Retinal Detachment | Isotretinoin: Isotretinoin 20mg daily for 12 weeks |
| BG001 | Recurrent RD Associated With PVR | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy Isotretinoin: Isotretinoin 20mg daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Retinal Attachment | We will evaluate all patients for retinal attachment at 3 months. | Posted | Count of Participants | Participants | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Primary, High-risk Retinal Detachment | Isotretinoin: Isotretinoin 20mg daily for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Kaiser, MD | MidAtlantic Retina | 215-928-3092 | research@midatlanticretina.com |
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| ID | Term |
|---|---|
| D018630 | Vitreoretinopathy, Proliferative |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Recurrent RD Associated With PVR | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy Isotretinoin: Isotretinoin 20mg daily for 12 weeks | 0 | 54 | 0 | 54 |
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| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |