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
  Purpose

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


Condition Intervention Phase
Retinal Detachment
Drug: placebo
Drug: Minocycline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • BCVA [ Time Frame: changes of BCVA in 3 month ] [ Designated as safety issue: No ]
    outcome method of measurement: Snellen chart


Secondary Outcome Measures:
  • 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)


Study Start Date: December 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
100mg-
Drug: placebo
100mg,BD, fo three month
Placebo Comparator: minocyclin Drug: Minocycline
100mg

  Eligibility

Ages Eligible for Study:   8 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 )
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297816

Locations
Iran, Islamic Republic of
Labbafinejad medical center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mohsen Azarmina, Associate Professor    00982122585952    labbafi@hotmail.com   
Principal Investigator: Mohsen Azarmina, Associate Professor         
Sponsors and Collaborators
Shahid Beheshti Medical University
  More Information

No publications provided

Responsible Party: Mohsen Azarmina, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01297816     History of Changes
Other Study ID Numbers: 89122
Study First Received: January 19, 2011
Last Updated: February 16, 2011
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014