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Evaluation of Neuroprotective Effect of Minocycline (minocyclin &RD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT01297816
First received: January 19, 2011
Last updated: February 16, 2011
Last verified: December 2010

January 19, 2011
February 16, 2011
December 2010
December 2010   (final data collection date for primary outcome measure)
BCVA [ Time Frame: changes of BCVA in 3 month ] [ Designated as safety issue: No ]
outcome method of measurement: Snellen chart
Same as current
Complete list of historical versions of study NCT01297816 on ClinicalTrials.gov Archive Site
  • finding of ERG changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    outcome method of measurement: ERG( testes)
  • finding of OCT changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    outcome method of measurement: OCT
  • finding of FAF changes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    outcome method of measurement: FAF( testes)
Same as current
Not Provided
Not Provided
 
Evaluation of Neuroprotective Effect of Minocycline
Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Retinal Detachment
  • Drug: placebo
    100mg,BD, fo three month
  • Drug: Minocycline
    100mg
  • Placebo Comparator: placebo
    100mg-
    Intervention: Drug: placebo
  • Placebo Comparator: minocyclin
    Intervention: Drug: Minocycline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
April 2011
December 2010   (final data collection date for primary outcome measure)

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 )
Both
8 Years and older
No
Iran, Islamic Republic of
 
NCT01297816
89122
Yes
Mohsen Azarmina, Ophthalmic Research center
Shahid Beheshti Medical University
Not Provided
Not Provided
Shahid Beheshti Medical University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP