Evaluation of Neuroprotective Effect of Minocycline | NCT01297816

Studies
Evaluation of Neuroprotective Effect of Minocycline

NCT01297816

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Unknown status

Last Update Posted

Feb 17, 2011Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Retinal Detachment

Interventions

placebo
Minocycline

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2010

Primary Completion Date

Dec 2010Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Jan 19, 2011

First Submission Date that Met QC Criteria

Feb 16, 2011

First Posted Date

Feb 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 16, 2011

Last Update Posted Date

Feb 17, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
placebo	Placebo Comparator	100mg-	Drug: placebo
minocyclin	Placebo Comparator		Drug: Minocycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
placebo	Drug	100mg,BD, fo three month	placebo
Minocycline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BCVA	outcome method of measurement: Snellen chart	changes of BCVA in 3 month

Secondary Outcomes

Measure	Description	Time Frame
finding of ERG changes	outcome method of measurement: ERG( testes)	3 months
finding of OCT changes	outcome method of measurement: OCT

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 )

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Labbafinejad medical center	Recruiting	Tehran	Tehran Province		Iran

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008911	Minocycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided