We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Neuroprotective Effect of Minocycline (minocyclin &RD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297816
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  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 (Participant, 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 University of Medical Sciences:

Primary Outcome Measures:
  • BCVA [ Time Frame: changes of BCVA in 3 month ]
    outcome method of measurement: Snellen chart


Secondary Outcome Measures:
  • finding of ERG changes [ Time Frame: 3 months ]
    outcome method of measurement: ERG( testes)

  • finding of OCT changes [ Time Frame: 3 months ]
    outcome method of measurement: OCT

  • finding of FAF changes [ Time Frame: 3 months ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University of Medical Sciences
  More Information

Responsible Party: Mohsen Azarmina, Ophthalmic Research center
ClinicalTrials.gov Identifier: NCT01297816     History of Changes
Other Study ID Numbers: 89122
First Submitted: January 19, 2011
First Posted: February 17, 2011
Last Update Posted: February 17, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Retinal Detachment
Retinal Diseases
Eye Diseases
Minocycline
Neuroprotective Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protective Agents
Physiological Effects of Drugs