1. Determination of the effect of intravitreal injection of bevacizumab (Avastin) along with correction of vitamin D deficiency on central macular thickness in patients with diabetic macular edema and vitamin D deficiency; 2. Determination of the effect of intravitreal injection of bevacizumab (Avastin) with correction of vitamin D deficiency on corrected distance visual acuity (CDVA) in patients with diabetic macular edema and vitamin D deficiency; 3. Determining the relationship between vitamin D levels and the severity of macular edema
Design
Clinical trial with parallel and randomized groups & control group
Settings and conduct
The study will be performed in the retinal clinic of Labbafinejad Hospital in Tehran.Both groups receive 3 baseline IVB as a base, and oral vitamin D supplement is prescribed for correction of deficiency in group 2 by 50000 units/week for eight weeks. No blinding is designed.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: Patients with type 2 diabetes mellitus and diabetic macular edema (DME) with greater central macular thickness of equal to and greater than 300 microns and corrected distance visual acuity of more than 0.1 LogMAR; Main exclusion criteria: Severe Vitamin D Deficiency (Less than 10 ng / ml), Taking vitamins Supplements upon entry
Intervention groups
Group 1 = Control Group = Deficient / Insufficient without Supplementation= with vitamin D deficiency and diabetic macular edema receiving IVB only; Group 2 = Deficient / Insufficient with Supplementation: With vitamin D deficiency and diabetic macular edema which will receive IVB and oral vitamin D supplementation (intervention)
Main outcome variables
Corrected distance visual acuity, central macular thickness, vitamin D level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200407046978N1
Registration date:2020-04-11, 1399/01/23
Registration timing:prospective
Last update:2020-04-11, 1399/01/23
Update count:0
Registration date
2020-04-11, 1399/01/23
Registrant information
Name
Sepehr Roozdar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2685 4764
Email address
roozdars@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-04, 1399/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravitreal bevacizumab (Avastin®) plus vitamin D supplementation on diabetic macular edema in vitamin D deficient patients
Public title
Evaluation of vitamin D effect on diabetic macular edema
Purpose
Treatment
Inclusion/Exclusion 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:
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 (<10 ng/ml)
Macular disease and consequent visual impairment due to causes other than diabetic macular edema
Hypercalcemia and hyperphosphatemia
Serum creatinin > 3 mg/dl
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple and individual randomization using tables of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committiee of Shahid Beheshti University of Medical Sciences
Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
Primary outcomes
1
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients with insufficient/ deficient leveLs of vitamin D and diabetic macular edema; Intervention: IVB
Category
Treatment - Drugs
2
Description
Intervention group: Patients with insufficient/deficient levels of vitamin D and diabetic macular edema; Intervention: IVB+Vitamin D oral supplementation