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Evaluation of vitamin D effect on diabetic macular edema

Effect of intravitreal bevacizumab (Avastin®) plus vitamin D supplementation on diabetic macular edema in vitamin D deficient patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200407046978N1
Enrollment
60
Registered
2020-04-11
Start date
2020-05-04
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic macular edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

Interventions

Intervention 1: Control group: Patients with insufficient/ deficient leveLs of vitamin D and diabetic macular edema
Intervention: IVB. Intervention 2: Intervention group: Patients with insufficient/deficient levels of vitamin D and diabetic macular edema
Intervention: IVB+Vitamin D oral supplementation.

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with diabetes mellitus type 2 and diabetic macular edema Central macular thickness equal and greater than 300 micron Corrected distance visual acuity of greater than 0.1 LogMAR

Exclusion criteria

Exclusion criteria: History of any intraocular surgery (except uncomplicated cataract surgery which at least 6 months are passed) History of intravitreal injection of bevacizumab, other anti-VEGFs and steroid within 3 past months Epiretinal membrane or vitreomacular traction History of retinal vascular accidents History of uveitis Pregnant or breastfeeding women Using vitamin supplementation Not taking vitamin D supplementation based on the study protocol during follow up period Patients with severe vitamin D deficiency ( 3 mg/dl

Design outcomes

Primary

MeasureTime frame
Change in central macular thickness in microns. Timepoint: Before treatment, 1 month, 3 months and 6 months after third baseline IVB. Method of measurement: Optical coherence tomography device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSepehr Roozdar

Shahid Beheshti University of Medical Sciences

roozdars@gmail.com+98 21 2685 4764

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026