Macular Edema Due to Type 2 Diabetes MellitusVEGFNCT05759884
Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
A study testing Anti-VEGF and subthreshold micropulse laser in people with Macular Edema Due to Type 2 Diabetes Mellitus, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema Due to Type 2 Diabetes Mellitus
- What is being tested?
- Anti-VEGF and subthreshold micropulse laser
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2022to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-proliferative diabetic retinopathy (NPDR) meeting diagnostic criteria: the diagnosis can be made by fundus examination, fluorescein fundus angiography (FFA) and optical coherence tomography (OCT), which meet the clinical significant macular edema (CSME) definition criteria, i.e. hard exudation within 500μm of macular fovea with adjacent retinal thickening or edema within 500μm of macular fovea. Or the thickened area of the retina was > 1 disc diameter (D) and within 1 day of the fovea of the macula.
- OCT examination showed a thickened CMT (≥200μm) without hyperplasia or scar
- Standard logarithmic visual acuity charts measure the BCVA (LogMAR) range from 0.01 to 1.0
- Control of glycosylated hemoglobin (HbA1c) ≤10% during follow-up
- Patients voluntarily participate and sign informed consent
Who cannot join
- Patients with severe corneal opacity, cataract and vitreous hemorrhage were found to be affected by OCTA examination by ophthalmic examination.
- Patients with other eye diseases or other complications during follow-up, such as glaucoma (IOP>21mmHg), high myopia (≥-6.0D), and other fundus lesions, such as retinal detachment, vitreous macular traction, preretinal membrane, ischemic macular disease, optic neuritis and other diseases involving the retina and optic nerve.
- Patients who have previously received intraocular surgery, vitreous macular traction syndrome, proliferative diabetic retinopathy (PDR) resulting in vitreous hemorrhage or local retinal detachment requiring surgical treatment, and patients with a history of eye trauma.
- History of panretinal photocoagulation within 6 months prior to treatment or local/grille photocoagulation within 3 months prior to treatment.
- History of intravitreal injection of any steroid within 6 months prior to treatment.
- Patients with serious systemic diseases, such as cardiovascular and cerebrovascular diseases or hematopoietic system, patients who have undergone intracranial surgery or intracranial space-occupying lesions, and patients with mental disorders.
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- Can not cooperate with the ophthalmic examination or other reasons can not obtain the ideal OCTA image.
- Pregnant, pregnant or lactating women and patients allergic to drugs.
- Suspected or confirmed history of alcohol and drug abuse.
- Patients who are participating in clinical trials of other drugs. If one of the above meets and can be excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Zhiyong Zhang, MD. PhD, 13968059392, zhangzhiyong@zju.edu.cn
About this study
Official title: Efficacy Analysis of Anti-vascular Endothelial Growth Factor (VEGF) Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
The goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are:
- To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients.
- To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism.
Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.
- Being tested
- Anti-VEGF, subthreshold micropulse laser
- Keywords
- Macular Edema
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGFDrug
Intravitreous injection of anti-VEGF drugs
subthreshold micropulse laserRadiation
577nm micropulse laser photocoagulation therapy
| Study group | Role | What they receive |
|---|---|---|
| anti-VEGF combined SML therapy group | Experimental | The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy. Receives: Drug: Anti-VEGF; Radiation: subthreshold micropulse laser |
| anti-VEGF single therapy group | Active comparator | Only intravitreal injection of anti-VEGF drugs was given to patients. Receives: Drug: Anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
central macular thickness (CMT)
CMT
Measured: up to 6 months
Secondary outcomes (5)
best-corrected visual acuity (BCVA)
BCVA
Measured: up to 6 months
superficial capillary vessel density (SVD)
The vessel density of the superficial capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Measured: up to 6 months
deep capillary vessel density (DVD)
The vessel density of the deep capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Measured: up to 6 months
foveal avascular zone (FAZ)
The area of FAZ will be evaluated on 3×3 mm OCTA image.
Measured: up to 6 months
nonperfusion (NP)
The NP regions in the superficial and deep capillary plexuswere will be evaluated on the 3×3 mm OCTA Image by Image J software. The scores were as follows: 1 for 0~3 NP regions, 2 for 4~6 NP regions, and 3 for more than 6 NP regions.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 Feb 2022
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (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 Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759884
- Sponsor's protocol ID
- 2022-0022
- Acronym
- VEGF
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 8 Mar 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 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Anti-vascular Endothelial Growth Factor (VEGF) Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05759884
- Acronym / sponsor ID
- VEGF / 2022-0022
- Keywords
- Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Mar 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 goal of this clinical trial is to clarify the efficacy of anti-vascular endothelial growth factor (anti-VEGF) drugs combined with subthreshold micropulse laser (SML) therapy on retinal function and anatomical recovery in patients with diabetic macular edema (DME). The main questions it aims to answer are:
- To clarify the efficacy of anti-VEGF drugs combined with SML therapy on retinal function and anatomical recovery in DME patients.
- To explore the changes in visual acuity and optical coherence tomography angiography (OCTA) parameters before and after the treatment of DME with anti-VEGF drugs combined with SML, and further explore the changes in morphological characteristics of retinal microvessels and the potential treatment mechanism.
Participants will randomly be given Intravitreous injection of anti-VEGF drugs or anti-VEGF drugs combined with SML therapy. All participants will be followed up for 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-VEGF combined SML therapy group | Experimental | Drug: Anti-VEGF, Radiation: subthreshold micropulse laserThe patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy. |
| anti-VEGF single therapy group | Active comparator | Drug: Anti-VEGFOnly intravitreal injection of anti-VEGF drugs was given to patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with non-proliferative diabetic retinopathy (NPDR) meeting diagnostic criteria: the diagnosis can be made by fundus examination, fluorescein fundus angiography (FFA) and optical coherence tomography (OCT), which meet the clinical significant macular edema (CSME) definition criteria, i.e. hard exudation within 500μm of macular fovea with adjacent retinal thickening or edema within 500μm of macular fovea. Or the thickened area of the retina was > 1 disc diameter (D) and within 1 day of the fovea of the macula.
- OCT examination showed a thickened CMT (≥200μm) without hyperplasia or scar
- Standard logarithmic visual acuity charts measure the BCVA (LogMAR) range from 0.01 to 1.0
- Control of glycosylated hemoglobin (HbA1c) ≤10% during follow-up
- Patients voluntarily participate and sign informed consent
Key exclusion criteria (10 listed)
- Patients with severe corneal opacity, cataract and vitreous hemorrhage were found to be affected by OCTA examination by ophthalmic examination.
- Patients with other eye diseases or other complications during follow-up, such as glaucoma (IOP>21mmHg), high myopia (≥-6.0D), and other fundus lesions, such as retinal detachment, vitreous macular traction, preretinal membrane, ischemic macular disease, optic neuritis and other diseases involving the retina and optic nerve.
- Patients who have previously received intraocular surgery, vitreous macular traction syndrome, proliferative diabetic retinopathy (PDR) resulting in vitreous hemorrhage or local retinal detachment requiring surgical treatment, and patients with a history of eye trauma.
- History of panretinal photocoagulation within 6 months prior to treatment or local/grille photocoagulation within 3 months prior to treatment.
- History of intravitreal injection of any steroid within 6 months prior to treatment.
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 |
|---|---|---|
| Anti-VEGFIntravitreous injection of anti-VEGF drugs | Drug | anti-VEGF combined SML therapy group, anti-VEGF single therapy group |
| subthreshold micropulse laser577nm micropulse laser photocoagulation therapy | Radiation | anti-VEGF combined SML therapy group |
Primary outcome
central macular thickness (CMT)
Time frame: up to 6 months
CMT
5 secondary outcomes
best-corrected visual acuity (BCVA)
Time frame: up to 6 months
superficial capillary vessel density (SVD)
Time frame: up to 6 months
deep capillary vessel density (DVD)
Time frame: up to 6 months
foveal avascular zone (FAZ)
Time frame: up to 6 months
nonperfusion (NP)
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: No
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?
A study testing Anti-VEGF and subthreshold micropulse laser in people with Macular Edema Due to Type 2 Diabetes Mellitus, 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 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 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 Zhiyong Zhang, MD. PhD. (13968059392, zhangzhiyong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
central macular thickness (CMT) (time frame: up to 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 8 Mar 2023.