GlaucomaPhase 2AMCTNCT02805257
Ahmed Glaucoma Valve Surgery With Mitomycin-C
A Phase 2 study testing Mitomycin-C, Balanced Salt Solution and Ahmed Glaucoma Valve Implant in people with Glaucoma and Primary Open Angle Glaucoma, run by University of California, San Francisco at 4 sites in 4 countries.
Trial summary
This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma
- What is being tested?
- Mitomycin-C, Balanced Salt Solution and Ahmed Glaucoma Valve Implant
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 119 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Jun 2016to Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
- Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
- For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.
Who cannot join
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Pregnant or nursing women.
- Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
- Patients with nanophthalmos.
- Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
- No light perception vision.
Show all 10Show fewer
- VA <20/200 in non-study eye.
- Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.
- Previous scleral buckling procedure or silicone oil present.
- Uveitic glaucoma.
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
United States1 site
University of California, San Francisco
San Francisco, California, 94121
About this study
This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.
Read the detailed description
Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
- Being tested
- Mitomycin-C, Balanced Salt Solution, Ahmed Glaucoma Valve Implant
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitomycin-CDrug
Also called Mitosol
Intraoperative and postoperative injections of mitomycin-c/Mitosol
Balanced Salt SolutionOther
Also called BSS
Intraoperative and postoperative injections of BSS
Ahmed Glaucoma Valve ImplantProcedure or surgery
Implantation of Ahmed Valve in study eye
| Study group | Role | What they receive |
|---|---|---|
| Mitomycin-C | Experimental | 0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. Receives: Drug: Mitomycin-C; Procedure: Ahmed Glaucoma Valve Implant |
| Balanced Salt Solution (BSS) | Placebo comparator | 0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. Receives: Other: Balanced Salt Solution; Procedure: Ahmed Glaucoma Valve Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure After Surgery
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
Measured: 1 year
Secondary outcomes (7)
Intraocular Pressure After Surgery
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
Measured: 6 months
Number of Medications Postoperatively
Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.
Measured: 6 months
Visual Acuity
The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.
Measured: 6 months
Number of Medications Postoperatively
Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.
Measured: 1 year
Number of Participants With Intraoperative Complications
Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.
Measured: Day of Surgery
Visual Acuity
The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.
Measured: 1 year
Number of Participants With Postoperative Complications
Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Bascom Palmer Eye Institute, University of North Carolina, University of Colorado, Denver, University of Maryland, Zhongshan Ophthalmic Center, Sun Yat-sen University, Asociación para Evitar la Ceguera en México, Hospital Central Militar, Shri Ganesh Vinayak Eye Hospital
- Responsible party
- Sponsor
- Investigators
- Ying Han, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805257
- Sponsor's protocol ID
- IRB#16-18935
- Acronym
- AMCT
- Status last verified
- May 2022
- First submitted
- 15 Jun 2016
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans to share IPD to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ahmed Glaucoma Valve Surgery With Mitomycin-C
- ClinicalTrials.gov ID
- NCT02805257
- Acronym / sponsor ID
- AMCT / IRB#16-18935
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Bascom Palmer Eye Institute, University of North Carolina, University of Colorado, Denver, University of Maryland, Zhongshan Ophthalmic Center, Sun Yat-sen University, Asociación para Evitar la Ceguera en México, Hospital Central Militar, Shri Ganesh Vinayak Eye Hospital
- Study start
- Jun 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.
Detailed description
Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such as Ahmed valve implantation, which are conventional surgeries performed to control intraocular pressure in eyes, are sometimes associated with complications due to fibrosis. Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitomycin-C | Experimental | Drug: Mitomycin-C, Procedure: Ahmed Glaucoma Valve Implant0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. |
| Balanced Salt Solution (BSS) | Placebo comparator | Other: Balanced Salt Solution, Procedure: Ahmed Glaucoma Valve Implant0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.
- Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.
- For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.
Key exclusion criteria (10 listed)
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.
- Pregnant or nursing women.
- Previous cyclodestruction or glaucoma drainage device (GDD) surgery.
- Patients with nanophthalmos.
- Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.
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-CAlso: MitosolIntraoperative and postoperative injections of mitomycin-c/Mitosol | Drug | Mitomycin-C |
| Balanced Salt SolutionAlso: BSSIntraoperative and postoperative injections of BSS | Other | Balanced Salt Solution (BSS) |
| Ahmed Glaucoma Valve ImplantImplantation of Ahmed Valve in study eye | Procedure or surgery | Balanced Salt Solution (BSS), Mitomycin-C |
Primary outcome
Intraocular Pressure After Surgery
Time frame: 1 year
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
7 secondary outcomes
Intraocular Pressure After Surgery
Time frame: 6 months
Number of Medications Postoperatively
Time frame: 6 months
Visual Acuity
Time frame: 6 months
Number of Medications Postoperatively
Time frame: 1 year
Number of Participants With Intraoperative Complications
Time frame: Day of Surgery
Visual Acuity
Time frame: 1 year
Number of Participants With Postoperative Complications
Time frame: 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No current plans to share IPD to other researchers.
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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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.
Ying Han, MD, PhD principal investigator
University of California, San Francisco
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitomycin-C, Balanced Salt Solution and Ahmed Glaucoma Valve Implant in people with Glaucoma and Primary Open Angle Glaucoma, run by University of California, San Francisco at 4 sites in 4 countries.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, China, India, Mexico. 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?
Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraocular Pressure After Surgery (time frame: 1 year). 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 31 May 2022.