Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01445028
Recruitment Status : Completed
First Posted : October 3, 2011
Results First Posted : May 11, 2017
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Proliferative Vitreoretinopathy
Intervention Drug: Isotretinoin
Enrollment 109
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Hide Arm/Group Description Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Period Title: Overall Study
Started 58 54
Completed 58 51
Not Completed 0 3
Arm/Group Title Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR Total
Hide Arm/Group Description Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Total of all reporting groups
Overall Number of Baseline Participants 58 51 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 51 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  87.9%
35
  68.6%
86
  78.9%
>=65 years
7
  12.1%
16
  31.4%
23
  21.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 51 participants 109 participants
56.8  (10.0) 59.7  (11.8) 57.1  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 51 participants 109 participants
Female
15
  25.9%
11
  21.6%
26
  23.9%
Male
43
  74.1%
40
  78.4%
83
  76.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 58 participants 51 participants 109 participants
58 51 109
1.Primary Outcome
Title Rate of Retinal Attachment
Hide Description We will evaluate all patients for retinal attachment at 3 months.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Hide Arm/Group Description:
Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Overall Number of Participants Analyzed 58 51
Measure Type: Count of Participants
Unit of Measure: Participants
50
  86.2%
42
  82.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Hide Arm/Group Description Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks

All-Cause Mortality
Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/54 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Primary, High-risk Retinal Detachment Recurrent RD Associated With PVR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/54 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Richard Kaiser, MD
Organization: MidAtlantic Retina
Phone: 215-928-3092
EMail: research@midatlanticretina.com
Layout table for additonal information
Responsible Party: Richard S. Kaiser, Wills Eye
ClinicalTrials.gov Identifier: NCT01445028     History of Changes
Other Study ID Numbers: WEI-DELIVER
First Submitted: September 29, 2011
First Posted: October 3, 2011
Results First Submitted: March 31, 2017
Results First Posted: May 11, 2017
Last Update Posted: June 1, 2018