GlaucomaNCT02744690
Mitomycin C Trabeculectomy Trial for Glaucoma in Ethiopia
A study testing Mitomycin-C (MMC) in people with Glaucoma, run by University of California, San Francisco at 1 site in Ethiopia.
Trial summary
This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Mitomycin-C (MMC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Mar 2015to 1 Mar 2019
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >=40
- Planning to have a trabeculectomy
Who cannot join
- Life threatening or debilitating disease
- Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- Pseudophakic lens
- Contralateral eye already enrolled in study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
This study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.
Read the detailed description
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
- Conditions
- Glaucoma
- Being tested
- Mitomycin-C (MMC)
- Keywords
- Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy
- Medical subject headings
- Glaucoma, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin-C (MMC)Drug
Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital
| Study group | Role | What they receive |
|---|---|---|
| MMC Injection | Experimental | Intervention: At the intended surgical site and about 6mm from the limbus, 0.2ml of 0.2mg/ml of mitomycin-C (MMC) will be injected subconjunctivally before peritomy Receives: Drug: Mitomycin-C (MMC) |
| MMC Sponge Application | Active comparator | Intervention: After peritomy, three half-sponges soaked in 0.2mg/ml mitomycin-C (MMC) will be placed posterior to the area of intended filtration. After 2 minutes, the sponges will be removed Receives: Drug: Mitomycin-C (MMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery
Measured: 3 months after surgery
Secondary outcomes (2)
Cumulative incidence of complications
Comparison of the cumulative incidence of complications between the treatment groups (sponge and injection application of MMC) 6 months and 12 months after surgery
Measured: 6 and 12 months after surgery
Reduction of intraocular pressure from baseline, mmHg
The investigators will compare the reduction of IOP from baseline between the treatment groups at 3, 6, and 12 months after surgery
Measured: 3, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start1 Mar 2015 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Why it stopped: The necessary ethical approvals were not obtained in a timely manner.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Menelik II Hospital
- Responsible party
- Sponsor
- Investigators
- Jeremy D Keenan, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744690
- Sponsor's protocol ID
- 15-16075-MMC
- Status last verified
- Jul 2023
- First submitted
- 11 Feb 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical vs Injection Application of Mitomycin C Trabeculectomy Trial
- ClinicalTrials.gov ID
- NCT02744690
- Acronym / sponsor ID
- 15-16075-MMC
- Conditions
- Glaucoma
- Keywords
- Eye Disease, Intraocular Pressure, Visual Acuity, Trabeculectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The necessary ethical approvals were not obtained in a timely manner.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Menelik II Hospital
- Study start
- 1 Mar 2015 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 20 Apr 2016 (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 study is a randomized, double-masked trial to examine the response to trabeculectomy surgery. In this study, patients will be randomized to receive MMC via subconjunctival injection or topical sponge application.
Detailed description
This study is a randomized, double-masked (study participants and outcome assessors) trial. During the enrollment period, patients from Menelik Hospital who are planning to have trabeculectomy surgery and who meet the study enrollment criteria will be randomized to receive mitomycin C applied topically or by injection during the surgery.At Menelik Hospital mitomycin-C (MMC) is routinely applied to the eye prior to trabeculectomy by physicians via both sponge and injection routes. The primary outcome is the patient's response to the trabeculectomy procedure, as measured by cumulative complications after a 3-month follow-up period post-operation. Secondary outcome is the change in intraocular pressure after a 3 month follow-up period. The investigators will perform subgroup analyses by stratifying the population according to skin pigmentation to determine whether pigmentation is a predictor of treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMC Injection | Experimental | Drug: Mitomycin-C (MMC)Intervention: At the intended surgical site and about 6mm from the limbus, 0.2ml of 0.2mg/ml of mitomycin-C (MMC) will be injected subconjunctivally before peritomy |
| MMC Sponge Application | Active comparator | Drug: Mitomycin-C (MMC)Intervention: After peritomy, three half-sponges soaked in 0.2mg/ml mitomycin-C (MMC) will be placed posterior to the area of intended filtration. After 2 minutes, the sponges will be removed |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >=40
- Planning to have a trabeculectomy
Key exclusion criteria (4 listed)
- Life threatening or debilitating disease
- Inability to complete necessary exams and/or ocular disease that would preclude assessment of intraocular pressure, visual field, or optic disc
- Pseudophakic lens
- Contralateral eye already enrolled in 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 |
|---|---|---|
| Mitomycin-C (MMC)Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital | Drug | MMC Injection, MMC Sponge Application |
Primary outcome
Cumulative incidence of complications
Time frame: 3 months after surgery
Comparison of the cumulative incidence of complications between the treatment groups (MMC sponge and injection application) 3 months after surgery
2 secondary outcomes
Cumulative incidence of complications
Time frame: 6 and 12 months after surgery
Reduction of intraocular pressure from baseline, mmHg
Time frame: 3, 6, and 12 months after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
Jeremy D Keenan, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mitomycin-C (MMC) in people with Glaucoma, run by University of California, San Francisco at 1 site in Ethiopia.
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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 1 Aug 2023. 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 Ethiopia. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of complications (time frame: 3 months after surgery). 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 1 Aug 2023.