Evaluation of Neuroprotective Effect of Minocycline

Retinal Detachment Clinical Trial

— minocyclin &RD  

Official title:

Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01297816
• Other study ID #: 89122
• Status: Recruiting
• Phase: Phase 2
• First received: January 19, 2011
• Last updated: February 16, 2011
• Start date: December 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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 )

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Retinal Detachment

Intervention

Drug:
• placebo
100mg,BD, fo three month
• Minocycline
100mg

Locations

Country	Name	City	State
Iran, Islamic Republic of	Labbafinejad medical center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA	outcome method of measurement: Snellen chart	changes of BCVA in 3 month	No
Secondary	finding of ERG changes	outcome method of measurement: ERG( testes)	3 months	No
Secondary	finding of OCT changes	outcome method of measurement: OCT	3 months	No
Secondary	finding of FAF changes	outcome method of measurement: FAF( testes)	3 months	No