GlaucomaNCT05892185
Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma
A study testing GELA and XEN in people with Glaucoma, run by Mingche Biotechnology CO., LTD.
Trial summary
The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- GELA and XEN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2023to 19 Jul 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.
Who cannot join
None listed.
About this study
Official title: A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.
The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.
Read the detailed description
A prospective, randomized, single-blind, positive control design was used to study primary open-angle glaucoma. Eligible subjects were screened and randomly assigned to the experimental group and the control group.
- Conditions
- Glaucoma
- Being tested
- GELA, XEN
- Keywords
- Glaucoma Implant
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GELADevice
GELA glaucoma implant
XENDevice
XEN gel stent implant
| Study group | Role | What they receive |
|---|---|---|
| GELA | Experimental | Participants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery) Receives: Device: GELA |
| XEN | Active comparator | Participants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery). Receives: Device: XEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate at 6 months after surgery
Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 6 month after surgery.
Measured: 6 months
Secondary outcomes (4)
IOP reduction
The IOP of the subjects before and 6 months after surgery was calculated in both experiment group and control group.
Measured: 6 months
topical IOP-lowering medications
Counting by class of drug of topical IOP lowering medications before and 6-month after surgery.
Measured: 6 months
Success rate 12 months after operation
Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 12 month after surgery.
Measured: 12 months
Adverse event
Adverse events was recorded and summarized.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start31 May 2023 (estimated)
- Primary completion12 Jan 2024 (estimated)
- Study completion19 Jul 2024 (estimated)
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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingche Biotechnology CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892185
- Sponsor's protocol ID
- MC-001-081
- Status last verified
- May 2023
- First submitted
- 23 May 2023
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Glaucoma Implant in Primary Open Angle Glaucoma.
- ClinicalTrials.gov ID
- NCT05892185
- Acronym / sponsor ID
- MC-001-081
- Conditions
- Glaucoma
- Keywords
- Glaucoma Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mingche Biotechnology CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 31 May 2023 (estimated)
- Primary completion
- 12 Jan 2024 (estimated)
- Study completion
- 19 Jul 2024 (estimated)
- First posted
- 7 Jun 2023 (actual)
- 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.
The objective of this study is to evaluate the efficacy and safety of glaucoma device in the treatment of primary open-angle glaucoma.
Detailed description
A prospective, randomized, single-blind, positive control design was used to study primary open-angle glaucoma. Eligible subjects were screened and randomly assigned to the experimental group and the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GELA | Experimental | Device: GELAParticipants underwent at least one preoperative visit and had GELA implantation on Day 0 (The day of surgery) |
| XEN | Active comparator | Device: XENParticipants underwent at least one preoperative visit and had XEN gel stent implantation on Day 0 (The day of surgery). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a clinical diagnosis of primary open-angle glaucoma (POAG) who could undergo minimally invasive glaucoma surgery (MIGS) as judged by the investigator.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GELAGELA glaucoma implant | Device | GELA |
| XENXEN gel stent implant | Device | XEN |
Primary outcome
Success rate at 6 months after surgery
Time frame: 6 months
Success rate defined as the percentage of total cases in which IOP decreased ≥20% and/or IOP ≤21mmHg while using the same or lower amount of IOP-lowering medications compared to baseline at 6 month after surgery.
4 secondary outcomes
IOP reduction
Time frame: 6 months
topical IOP-lowering medications
Time frame: 6 months
Success rate 12 months after operation
Time frame: 12 months
Adverse event
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GELA and XEN in people with Glaucoma, run by Mingche Biotechnology CO., LTD.
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 0 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 7 Jun 2023. 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.
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?
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?
Success rate at 6 months after surgery (time frame: 6 months). 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 7 Jun 2023.