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Completed

NCT Number: NCT01445028

Isotretinoin for 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.

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Key information

Conditions

Proliferative Vitreoretinopathy Eye Diseases Retinal Diseases Vitreoretinopathy, Proliferative

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

isotretinoin

Drug

Isotretinoin 20mg daily for 12 weeks

Primary outcomes

  1. Rate of Retinal Attachment

    Time frame: 3 months

    We will evaluate all patients for retinal attachment at 3 months.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

Determining the Effect of Low-dose Isotretinoin on Proliferative Vitreoretinopathy

Acronym: DELIVER

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Oct 3, 2011
Registry last updated
Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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