search
Back to results

Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema (VEGF)

Primary Purpose

Macular Edema Due to Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anti-VEGF
subthreshold micropulse laser
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Edema Due to Type 2 Diabetes Mellitus focused on measuring Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Sites / Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

anti-VEGF combined SML therapy group

anti-VEGF single therapy group

Arm Description

The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy.

Only intravitreal injection of anti-VEGF drugs was given to patients.

Outcomes

Primary Outcome Measures

central macular thickness (CMT)
CMT

Secondary Outcome Measures

best-corrected visual acuity (BCVA)
BCVA
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.
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.
foveal avascular zone (FAZ)
The area of FAZ will be evaluated on 3×3 mm OCTA image.
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.

Full Information

First Posted
February 8, 2023
Last Updated
February 26, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT05759884
Brief Title
Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
Acronym
VEGF
Official Title
Efficacy Analysis of Anti-vascular Endothelial Growth Factor (VEGF) Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Due to Type 2 Diabetes Mellitus
Keywords
Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-VEGF combined SML therapy group
Arm Type
Experimental
Arm Description
The patients were treated with intravitreal injection of anti-VEGF drugs and SML therapy.
Arm Title
anti-VEGF single therapy group
Arm Type
Active Comparator
Arm Description
Only intravitreal injection of anti-VEGF drugs was given to patients.
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF
Intervention Description
Intravitreous injection of anti-VEGF drugs
Intervention Type
Radiation
Intervention Name(s)
subthreshold micropulse laser
Intervention Description
577nm micropulse laser photocoagulation therapy
Primary Outcome Measure Information:
Title
central macular thickness (CMT)
Description
CMT
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
best-corrected visual acuity (BCVA)
Description
BCVA
Time Frame
up to 6 months
Title
superficial capillary vessel density (SVD)
Description
The vessel density of the superficial capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Time Frame
up to 6 months
Title
deep capillary vessel density (DVD)
Description
The vessel density of the deep capillary plexus level will be analyzed in the 3×3 mm OCTA scanning mode.
Time Frame
up to 6 months
Title
foveal avascular zone (FAZ)
Description
The area of FAZ will be evaluated on 3×3 mm OCTA image.
Time Frame
up to 6 months
Title
nonperfusion (NP)
Description
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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiyong Zhang, MD. PhD.
Phone
13968059392
Email
zhangzhiyong@zju.edu.cn
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyong Zhang, MD. PhD
Phone
13968059392
Email
zhangzhiyong@zju.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema

We'll reach out to this number within 24 hrs