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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014