GlaucomaPhase 3conj mmcNCT02385370
Bleb Function and Morphology With Intratendon Injection of MMC Compared With Standard Method
A Phase 3 study testing MMC in people with Glaucoma, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with advanced glaucoma that are candidates for trabeculectomy will be included. Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- MMC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteIran
- Study dates
- Dec 2014to Dec 2015
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced uncontrolled glaucoma patients.
Who cannot join
- History of any kind of intraocular surgery.
- Monocular patients.
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Study site
Tehran
mohammad pakravan, 009822591616, labbafi@hotmail.com
About this study
Official title: Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy
Patients with advanced glaucoma that are candidates for trabeculectomy will be included.
Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.
- Conditions
- Glaucoma
- Being tested
- MMC
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMCDrug
using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
MMCDrug
0.1 cc of 0.01% MMC is injected into the tenon.
| Study group | Role | What they receive |
|---|---|---|
| using standard method of applying MMC | Active comparator | applying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes Receives: Drug: MMC |
| intratendon injection of MMC | Active comparator | intratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure Receives: Drug: MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP (intraocular pressure)
Goldmann applanation tonometry
Measured: until 6 months
Secondary outcomes (1)
Bleb morphology
scoring the bleb morphologic features according to Indian Grading System
Measured: until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385370
- Sponsor's protocol ID
- 92181
- Acronym
- conj mmc
- Status last verified
- Dec 2014
- First submitted
- 4 Mar 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18.
PubMed 28100482
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bleb Function and Morphology With Intratendon Injection of 0.1 mg MMC in Comparison With Conventional Subtenon Application of 0.02% MMC Soaked Sponges in Trabeculectomy
- ClinicalTrials.gov ID
- NCT02385370
- Acronym / sponsor ID
- conj mmc / 92181
- Conditions
- Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 11 Mar 2015 (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.
Patients with advanced glaucoma that are candidates for trabeculectomy will be included.
Thorough ophthalmic examination including best corrected visual acuity, slit lamp examination, intraocular pressure (IOP) measurement, gonioscopy, funduscopy and specularly microscopy will be performed for all participants. Patients will be assigned randomly to 2 groups. In one group they will undergo fornix based trabeculectomy with conventional MMC 0.02% soaked sponges application. In the other group 0.1 cc of 0.01 MMC will be injected into the tenon at the beginning of the surgery. The rest of the operation is the same for both groups as standard trabeculectomy. Ophthalmic examination including IOP measurement will be performed at one, 3 and 6th month post surgery. Specular microscopy will be requested at final follow up visit. Bleb morphology will be scored according to Indian grading system at 3rd and 6th months post surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| using standard method of applying MMC | Active comparator | Drug: MMCapplying MMC 0.02 % soaked sponges under conjunctival space for 1 to 3 minutes |
| intratendon injection of MMC | Active comparator | Drug: MMCintratendon injection of 0.1 cc MMC 0.01% at the beginning of the procedure |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced uncontrolled glaucoma patients.
Key exclusion criteria (3 listed)
- History of any kind of intraocular surgery.
- Monocular patients.
- Unwillingness to participate in the study
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 |
|---|---|---|
| MMCusing 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes | Drug | using standard method of applying MMC |
| MMC0.1 cc of 0.01% MMC is injected into the tenon. | Drug | intratendon injection of MMC |
Primary outcome
IOP (intraocular pressure)
Time frame: until 6 months
Goldmann applanation tonometry
1 secondary outcome
Bleb morphology
Time frame: until 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2015.
- Derived from this study: PubMed 28100482Pakravan M, Esfandiari H, Yazdani S, Douzandeh A, Amouhashemi N, Yaseri M, Pakravan P. Mitomycin C-augmented trabeculectomy: subtenon injection versus soaked sponges: a randomised clinical trial. Br J Ophthalmol. 2017 Sep;101(9):1275-1280. doi: 10.1136/bjophthalmol-2016-309671. Epub 2017 Jan 18.
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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 3 study testing MMC in people with Glaucoma, 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 1 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 11 Mar 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact mohammad pakravan (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (intraocular pressure) (time frame: until 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385370, which also lists 1 linked publication.
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 11 Mar 2015.