minocyclin &RD: Evaluation of Neuroprotective Effect of Minocycline

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01297816
• Collaborator: (none)
• Location: 1
• Arms: 2
• Duration (Months): 4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment	Drug: placebo; Drug: Minocycline	Phase 2

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Dec 1, 2010
• Anticipated Primary Completion Date: Dec 1, 2010
• Anticipated Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo 100mg-	Drug: placebo; 100mg,BD, fo three month
Placebo Comparator: minocyclin	Drug: Minocycline; 100mg

Outcome Measures

Primary Outcome Measures

1. BCVA [changes of BCVA in 3 month]

   outcome method of measurement: Snellen chart

Secondary Outcome Measures

1. finding of ERG changes [3 months]

   outcome method of measurement: ERG( testes)

2. finding of OCT changes [3 months]

   outcome method of measurement: OCT

3. finding of FAF changes [3 months]

   outcome method of measurement: FAF( testes)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Labbafinejad medical center	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01297816
• Other Study ID Numbers: 89122
• First Posted: Feb 17, 2011
• Last Update Posted: Feb 17, 2011
• Last Verified: Dec 1, 2010

• Additional relevant MeSH terms: Retinal Detachment; Minocycline

Study Results

No Results Posted as of Feb 17, 2011