Macular Edema Due to Diabetes MellitusNCT05529589
Comparison of Restoration in Vitreous Hemorrhage Patients With DME After or Not Removing Inner Limiting Membrane
An observational study of Macular Edema Due to Diabetes Mellitus and Vitreous Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Macular Edema Due to Diabetes Mellitus, Vitreous Hemorrhage
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2023to 30 Oct 2023
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with vitreous hemorrhage with DME who need vitreous surgery are of all ages and sexes
Who may be able to join
- Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery
Who cannot join
- The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
- The patient with a history of anti-VEGF therapy
- Patients with DME in the contralateral eye requiring anti-VEGF therapy
- Patients with contraindications of vitreous cavity resection
- The patient has a history of intraocular surgery
- The patient has active inflammatory disease
Show all 9Show fewer
- The patient has other retinal diseases that affect vision
- The patient has other systemic diseases that required treatment with anti-VEGF drugs
- Patient with contraindications to anti-VEGF therapy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2ndAffiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jian Ma, Doctor, 18858299889, jian_ma@zju.edu.cn
About this study
Official title: Comparative Study of Anti-VEGF Effect and Visual Function in Vitreous Hemorrhage Patients With Diabetic Macular Edema After Pars Plana Vitrectomy With Inner Limiting Membrane Peeling or Not
This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not
- Medical subject headings
- Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control group | Diabetic macular edema patient with inner limit membrane | |
| experimental group | Diabetic macular edema patient with inner limit membrane peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness change of retinal macular area
measurement of thickness of retinal macular area with macular optical coherence tomography after operation (0 day, 1 week, 1 months, 3 months, 6 months, 12 months)
Measured: 12 months
Change of visual acuity
measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
Measured: 12 months
Secondary outcomes (2)
Change of eye pressure
Measurement of contact tonometry with iCare TA01i tonometer after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
Measured: 12 months
B-mode ultrasound imaging
Existing or not of abnormal anatomical structure in posterior eye segment (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
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 Sep 2022
- Study start10 Feb 2023 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Due to Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529589
- Sponsor's protocol ID
- AVDME
- Status last verified
- Aug 2022
- First submitted
- 30 Aug 2022
- Last updated
- 6 Feb 2023
- Results posted
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Anti-VEGF Effect and Visual Function in Vitreous Hemorrhage Patients With Diabetic Macular Edema After Pars Plana Vitrectomy With Inner Limiting Membrane Peeling or Not
- ClinicalTrials.gov ID
- NCT05529589
- Acronym / sponsor ID
- AVDME
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2023 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 7 Sep 2022 (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.
This study is conducted to compare the anti-VEGF effect and visual function in vitreous hemorrhage patients with diabetic macular edema after pars plana vitrectomy with inner limiting membrane peeling or not
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –Diabetic macular edema patient with inner limit membrane |
| experimental group | – | –Diabetic macular edema patient with inner limit membrane peeling |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with vitreous hemorrhage with DME who need vitreous surgery are of all ages and sexes
Key inclusion criteria (1 listed)
- Patients with vitreous hemorrhage with diabetic macular edema and require vitreous surgery
Key exclusion criteria (9 listed)
- The patient's preoperative vitreous hemorrhage resulted in the failure of OCT to scan the macular region
- The patient with a history of anti-VEGF therapy
- Patients with DME in the contralateral eye requiring anti-VEGF therapy
- Patients with contraindications of vitreous cavity resection
- The patient has a history of intraocular surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thickness change of retinal macular area
Time frame: 12 months
measurement of thickness of retinal macular area with macular optical coherence tomography after operation (0 day, 1 week, 1 months, 3 months, 6 months, 12 months)
Change of visual acuity
Time frame: 12 months
measurement of distance visual acuity with subjective refraction after operation (0 day, 1 week, 1 month, 3 months, 6 months, 12 months)
2 secondary outcomes
Change of eye pressure
Time frame: 12 months
B-mode ultrasound imaging
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 6 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema Due to Diabetes Mellitus and Vitreous Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 9 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 6 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Ma, Doctor (18858299889, jian_ma@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thickness change of retinal macular area (time frame: 12 months). The study lists 2 primary outcomes in all. 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 6 Feb 2023.