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Isotretinoin for Proliferative Vitreoretinopathy (DELIVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard S. Kaiser, Wills Eye
ClinicalTrials.gov Identifier:
NCT01445028
First received: September 29, 2011
Last updated: March 31, 2017
Last verified: March 2017
Results First Received: March 31, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Primary, High-risk Retinal Detachment Isotretinoin: Isotretinoin 20mg daily for 12 weeks
Recurrent RD Associated With PVR

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks


Participant Flow:   Overall Study
    Primary, High-risk Retinal Detachment   Recurrent RD Associated With PVR
STARTED   58   54 
COMPLETED   58   51 
NOT COMPLETED   0   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Primary, High-risk Retinal Detachment Isotretinoin: Isotretinoin 20mg daily for 12 weeks
Recurrent RD Associated With PVR

Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy

Isotretinoin: Isotretinoin 20mg daily for 12 weeks

Total Total of all reporting groups

Baseline Measures
   Primary, High-risk Retinal Detachment   Recurrent RD Associated With PVR   Total 
Overall Participants Analyzed 
[Units: Participants]
 58   51   109 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 56.8  (10.0)   59.7  (11.8)   57.1  (10.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      15  25.9%      11  21.6%      26  23.9% 
Male      43  74.1%      40  78.4%      83  76.1% 
Region of Enrollment 
[Units: Participants]
     
United States   58   51   109 


  Outcome Measures

1.  Primary:   Rate of Retinal Attachment   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Richard Kaiser, MD
Organization: MidAtlantic Retina
phone: 800-331-6634
e-mail: rkaiser@midatlanticretina.com



Responsible Party: Richard S. Kaiser, Wills Eye
ClinicalTrials.gov Identifier: NCT01445028     History of Changes
Other Study ID Numbers: WEI-DELIVER
Study First Received: September 29, 2011
Results First Received: March 31, 2017
Last Updated: March 31, 2017