| Trial ID: | L5174 |
| Source ID: | NCT05759884
|
| Associated Drug: |
Anti-Vegf
|
| Title: |
Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
|
| Acronym: |
VEGF
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Macular Edema Due to Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Anti-VEGF|RADIATION: subthreshold micropulse laser
|
| Outcome Measures: |
Primary: central macular thickness (CMT), CMT, up to 6 months | Secondary: best-corrected visual acuity (BCVA), BCVA, 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., 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., up to 6 months|foveal avascular zone (FAZ), The area of FAZ will be evaluated on 3×3 mm OCTA image., 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., up to 6 months
|
| Sponsor/Collaborators: |
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
40
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2022-02-01
|
| Completion Date: |
2024-06
|
| Results First Posted: |
|
| Last Update Posted: |
2023-03-08
|
| Locations: |
Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310000, China
|
| URL: |
https://clinicaltrials.gov/show/NCT05759884
|
