Proliferative VitreoretinopathyPhase 4DELIVERNCT01445028
Isotretinoin for Proliferative Vitreoretinopathy
A Phase 4 study testing Isotretinoin in people with Proliferative Vitreoretinopathy, run by Wills Eye at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
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.
Read the 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.
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- Isotretinoin
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Isotretinoin 20mg daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Primary, high-risk retinal detachment | Experimental | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy Receives: Drug: Isotretinoin |
| Recurrent RD associated with PVR | Experimental | Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Retinal Attachment
We will evaluate all patients for retinal attachment at 3 months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2013
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Proliferative VitreoretinopathyStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard S. Kaiser, Wills Eye
- Investigators
- Richard S Kaiser, MD, Principal investigator, Wills Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01445028
- Sponsor's protocol ID
- WEI-DELIVER
- Acronym
- DELIVER
- Status last verified
- Apr 2018
- First submitted
- 29 Sep 2011
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy
- ClinicalTrials.gov ID
- NCT01445028
- Acronym / sponsor ID
- DELIVER / WEI-DELIVER
- Conditions
- Proliferative Vitreoretinopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Oct 2011 (estimated)
- Results
- Posted 11 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary, high-risk retinal detachment | Experimental | Drug: IsotretinoinOral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy |
| Recurrent RD associated with PVR | Experimental | Drug: IsotretinoinOral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| IsotretinoinIsotretinoin 20mg daily for 12 weeks | Drug | Primary, high-risk retinal detachment, Recurrent RD associated with PVR |
Primary outcome
Rate of Retinal Attachment
Time frame: 3 months
We will evaluate all patients for retinal attachment at 3 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Richard S Kaiser, MD principal investigator
Wills Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isotretinoin in people with Proliferative Vitreoretinopathy, run by Wills Eye 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 11 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: finished, as of the sponsor's last update on 1 Jun 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Retinal Attachment (time frame: 3 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 1 Jun 2018.