NCT01297816

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

February 17, 2011

Status Verified

December 1, 2010

Enrollment Period

Same day

First QC Date

January 19, 2011

Last Update Submit

February 16, 2011

Conditions

Retinal Detachment

Outcome Measures

Primary Outcomes (1)

  • BCVA

    outcome method of measurement: Snellen chart

    changes of BCVA in 3 month

Secondary Outcomes (3)

  • finding of ERG changes

    3 months

  • finding of OCT changes

    3 months

  • finding of FAF changes

    3 months

Study Arms (2)

placebo

PLACEBO COMPARATOR

100mg-

Drug: placebo

minocyclin

PLACEBO COMPARATOR
Drug: Minocycline

Interventions

placeboDRUG

100mg,BD, fo three month

placebo
MinocyclineDRUG

100mg

minocyclin

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labbafinejad medical center

Tehran, Tehran Province, Iran

RECRUITING

MeSH Terms

Conditions

Retinal Detachment

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2011

First Posted

February 17, 2011

Study Start

December 1, 2010

Primary Completion

December 1, 2010

Study Completion

April 1, 2011

Last Updated

February 17, 2011

Record last verified: 2010-12

Locations

IR(1)