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Open Angle GlaucomaPhase 4NCT04352660

Subconjunctival Versus Direct Mitomycin C in Trabeculectomy

A Phase 4 study testing Mitomycin-C injection and Mitomycin-C sponge in people with Open Angle Glaucoma, run by University of California, San Diego.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Open Angle Glaucoma
What is being tested?
Mitomycin-C injection and Mitomycin-C sponge
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
23 May 2016to 14 Apr 2019
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • medically uncontrolled glaucoma
  • healthy and freely mobile conjunctiva in superior bulbar region

Who cannot join

  • previous incisional glaucoma surgery
  • no light perception vision
  • pregnant or nursing women
  • iris neovascularization or proliferative retinopathy
  • iridocorneal endothelial syndrome
  • chronic or recurrent uveitis
Show all 10Show fewer
  • steroid-induced glaucoma
  • pathologic myopia or refractive error less than -6.00 diopters
  • unwillingness or inability to give consent
  • inability to return for scheduled protocol visits

About this study

Official title: Subconjunctival Versus Direct Scleral Application of Mitomycin-C in Trabeculectomy

Trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. Success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically Mitomycin C (MMC). MMC can be applied to the eye at various sites, concentrations and times. This study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of IOP lowering effect, bleb appearance and complications.

Read the detailed description

Trabeculectomy is widely used as a surgical treatment of uncontrolled open glaucoma. Success of trabeculectomy at halting or slowing glaucoma progression primarily relies on the extent of conjunctival and sclera wound healing. The success rates of trabeculectomy increased dramatically with the introduction of anti-metabolites. For more than two decades mitomycin-c (MMC), a chemotherapeutic agent capable of decreasing fibroblast activity and modulating wound healing at the bleb, has been used with trabeculectomy. The complications of MMC are well known and several studies have described various methods of application based on exposure time, dose and surface area. Numerous retrospective and prospective studies have compared the efficacy of MMC applied beneath the conjunctival flap with soaked sponges versus intrascleral application. In 2008, Lee et al. first described an alternative route of application: subconjunctival injection of MMC directly into the intra-Tenon area. Seventy-six eyes with primary and secondary open angle glaucoma underwent trabeculectomy with this approach and were followed for one year post-operatively. Eighty-six percent of eyes achieved an IOP <21 mm Hg and 57% an IOP<14 mm Hg at one year without adjunctive drops. Transient complications included hyphema, bleb leak and choroidal detachment. The advantages of injected MMC are primarily in controlling the exact dosage and area of application and reduced surgical time. Lim et al. retrospectively reviewed the outcomes of trabeculectomy in 57 eyes using sponge application directly to the sclera versus intra-tenon injection. IOP was significantly lower in the injection group at 1 month, 1, 2, and 3 years. Trabeculectomy success (IOP<21mm Hg or IOP >20% below baseline without medications or additional surgery) was greater in the injection group at 3 years. The sponge group experienced more encapsulated blebs but complication rates were similar in both groups. To date, there have been no prospective studies comparing the IOP-lowering efficacy and safety of intra-tenon injection versus direct scleral application of MMC.

Being tested
Mitomycin-C injection, Mitomycin-C sponge
Keywords
trabeculectomy, mitomycin-C, glaucoma
Medical subject headings
Glaucoma, Open-Angle, Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitomycin-C injectionDrug

    MMC delivered by preoperative subconjunctival injection

  • Mitomycin-C spongeDrug

    MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges

Study groups in NCT04352660
Study groupRoleWhat they receive
Injection groupActive comparatorMMC delivered by preoperative subconjunctival injection
Receives: Drug: Mitomycin-C injection
Sponge groupActive comparatorMMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
Receives: Drug: Mitomycin-C sponge

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds

    Percentage of patients achieving at least a 30% mean intraocular pressure reductions from baseline and with an intraocular pressure <21 mm Hg. Subjects that met this criteria without the use of intraocular pressure lowering medications were classified as "Complete Success." Subjects that met this criteria but required the use of intraocular pressure lowering medications were classified as "Qualified Success." Subjects that failed to meet this criteria were classified as "Failure." Subjects that failed to meet this criteria and required additional glaucoma surgery were classified as "Complete Failure."

    Measured: 6 months

Secondary outcomes (6)

  1. Bleb Morphology

    Bleb morphology at 6 months was graded using Indiana Bleb Appearance Grading Scale. Bleb height was graded on a scale of 0 to 3 (0: flat bleb without visible elevation, 1: low bleb elevation, 2: moderate bleb elevation, 3: high bleb elevation). Bleb extent was graded on a scale of 0 to 3 (0: no visible bleb extent to less than 1 clock hour, 1: extent equal to or greater than 1 clock hour but less than 2 clock hours, 2: extent equal to or greater than 2 clock hours but less than 4 clock hours, 3: extent equal to or greater than 4 clock hours). Bleb vascularity was graded on a scale of 0 to 4 (0: avascular/white, 1: avascular/cystic, 2: mild vascularity, 3: moderate vascularity, 4: extensive vascularity). Scales are descriptive and do not necessarily represent better or worse outcomes.

    Measured: 6 months

  2. Medications

    Number of intraocular pressure lowering medications used by the patient at follow up visit.

    Measured: 6 months

  3. Visual Acuity

    Change in visual acuity from baseline

    Measured: 6 months

  4. Number of Participants With Surgical Complications

    Number of eyes that experienced surgical complications following surgery

    Measured: 6 months

  5. Number of Participants Requiring Additional Surgery

    Number of eyes requiring additional surgery from each group

    Measured: 6 months

  6. Postoperative Interventions

    Mean number of postoperative interventions (needling, antifibrotic injections) performed in each group

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2020
  2. Study start23 May 2016
  3. Primary completion14 Apr 2019
  4. Study completion14 Apr 2019

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04352660
Sponsor's protocol ID
151621
Status last verified
Jun 2020
First submitted
15 Apr 2020
Last updated
2 Jul 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mitomycin-C injection and Mitomycin-C sponge in people with Open Angle Glaucoma, run by University of California, San Diego.

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 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 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 2 Jul 2020). 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?

Percentage of Participants Achieving Intraocular Pressure Reduction Thresholds (time frame: 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 NCT04352660.

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 2 Jul 2020.

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