Retinal DetachmentPhase 2minocyclin &RDNCT01297816
Evaluation of Neuroprotective Effect of Minocycline
A Phase 2 study testing Minocycline in people with Retinal Detachment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Retinal Detachment
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Dec 2010to Apr 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 )
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad medical center
Tehran, Tehran Province
Mohsen Azarmina, Associate Professor, 00982122585952, labbafi@hotmail.com
Mohsen Azarmina, Associate Professor
About this study
Official title: Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery
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
- Conditions
- Retinal Detachment
- Being tested
- placebo, Minocycline
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
100mg,BD, fo three month
MinocyclineDrug
100mg
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | 100mg- Receives: Drug: placebo |
| minocyclin | Placebo comparator | Not described Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
outcome method of measurement: Snellen chart
Measured: changes of BCVA in 3 month
Secondary outcomes (3)
finding of ERG changes
outcome method of measurement: ERG( testes)
Measured: 3 months
finding of OCT changes
outcome method of measurement: OCT
Measured: 3 months
finding of FAF changes
outcome method of measurement: FAF( testes)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297816
- Sponsor's protocol ID
- 89122
- Acronym
- minocyclin &RD
- Status last verified
- Dec 2010
- First submitted
- 19 Jan 2011
- Last updated
- 17 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Minocycline Neuro Protective Role in Retinal Detachment Surgery
- ClinicalTrials.gov ID
- NCT01297816
- Acronym / sponsor ID
- minocyclin &RD / 89122
- Conditions
- Retinal Detachment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebo100mg- |
| minocyclin | Placebo comparator | Drug: Minocycline |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo100mg,BD, fo three month | Drug | placebo |
| Minocycline100mg | Drug | minocyclin |
Primary outcome
BCVA
Time frame: changes of BCVA in 3 month
outcome method of measurement: Snellen chart
3 secondary outcomes
finding of ERG changes
Time frame: 3 months
finding of OCT changes
Time frame: 3 months
finding of FAF changes
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline in people with Retinal Detachment, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: changes of BCVA in 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2011.