Evaluation of Neuroprotective Effect of Minocycline (minocyclin &RD)
Primary Purpose
Retinal Detachment
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
placebo
Minocycline
Sponsored by
About this trial
This is an interventional prevention trial for Retinal Detachment
Eligibility Criteria
Inclusion Criteria:
- age over 8 years old
- gender of both sex
- normal liver and renal function
- informed consent received from all patients
- no pregnancy and no lactation
- minimal sun exposure
Exclusion Criteria:
- old RD
- diabetic retina
- previous retinal surgery CRF& liver disfunction RD + PVR > B Hyper sensitivity to tetracycline History previous MPC or PRP Patients unsuccessful SB (retina is off )
Sites / Locations
- Labbafinejad medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Placebo Comparator
Arm Label
placebo
minocyclin
Arm Description
100mg-
Outcomes
Primary Outcome Measures
BCVA
outcome method of measurement: Snellen chart
Secondary Outcome Measures
finding of ERG changes
outcome method of measurement: ERG( testes)
finding of OCT changes
outcome method of measurement: OCT
finding of FAF changes
outcome method of measurement: FAF( testes)
Full Information
NCT ID
NCT01297816
First Posted
January 19, 2011
Last Updated
February 16, 2011
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01297816
Brief Title
Evaluation of Neuroprotective Effect of Minocycline
Acronym
minocyclin &RD
Official Title
Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
April 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This process appears as a incredible and progressive event that will not stop till reattachment of RPE and neurosensory retina happened .
Process of degeneration begins from first hours of RD (Retinal Detachment) establishment Neuroprotection of photoreceptor following RD is a novel and debatable discussion encountered in recent years .
How to stop this phenomena and neuroprotective agent role in this issue are a new interest of researcher.
In the study the investigators are planning to perform a clinical trial to demonstrate the minocycline neuroprotective effect in a double blind design as this impact has been implicated previously in a animal study
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
100mg-
Arm Title
minocyclin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
100mg,BD, fo three month
Intervention Type
Drug
Intervention Name(s)
Minocycline
Intervention Description
100mg
Primary Outcome Measure Information:
Title
BCVA
Description
outcome method of measurement: Snellen chart
Time Frame
changes of BCVA in 3 month
Secondary Outcome Measure Information:
Title
finding of ERG changes
Description
outcome method of measurement: ERG( testes)
Time Frame
3 months
Title
finding of OCT changes
Description
outcome method of measurement: OCT
Time Frame
3 months
Title
finding of FAF changes
Description
outcome method of measurement: FAF( testes)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age over 8 years old
gender of both sex
normal liver and renal function
informed consent received from all patients
no pregnancy and no lactation
minimal sun exposure
Exclusion Criteria:
old RD
diabetic retina
previous retinal surgery CRF& liver disfunction RD + PVR > B Hyper sensitivity to tetracycline History previous MPC or PRP Patients unsuccessful SB (retina is off )
Facility Information:
Facility Name
Labbafinejad medical center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen Azarmina, Associate Professor
Phone
00982122585952
Email
labbafi@hotmail.com
First Name & Middle Initial & Last Name & Degree
Mohsen Azarmina, Associate Professor
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Neuroprotective Effect of Minocycline
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