Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05083689
• Other study ID #: 14002
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: October 6, 2021
• Est. completion date: April 2022

Study information

• Verified date: October 2021
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a double-blind randomized clinical trial in Diabetic patients (type 2) over 18 years of age who have diabetic macular edema with involvement of the central 1 millimeter (central macular thickness is more than 300 μm) and BCVA 20/30 or less who visit the retina clinic of Labbafinejad Hospital Are studied. (In patients with bilateral macular edema, only one eye is included in the study.) Complete ocular examinations (including best corrected visual acuity - anterior segment - intraocular pressure - dilated pupil funduscopy with severity of diabetic retinopathy), optical coherence tomography (OCT), EDI-OCT( Enhanced Depth Imaging Optical Coherence Tomography ) - as well as Optical coherence tomography angiography (OCTA ) are performed for all patients at baseline. Blood tests are also taken from patients for fasting blood sugar and HbA1C. Patients are then randomly divided into two groups. The first group is treated with injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day. For the second group (control group), 3 injections of 1.25 mg of intravitreal bevacizumab monthly with artificial tears (twice a day as a placebo) are prescribed. Patients in both groups are visited 1 month after the third basic intravitreal bevacizumab (IVB) injection and complete ophthalmology examinations are performed and central thickness of macula is recorded based on the patient's OCT as well as the need for IVB re-injection. EDI (Enhanced Depth Imaging)-OCT and OCTA are performed again for all patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 62
• Est. completion date: April 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Diabetic Melitus type 2
• Patients with center-involving diabetic macular edema (central macular edema > 300 micrometer)
• Patients have diabetic retinopathy at the stage of nonproliferative diabetic retinopathy (NPDR) or early PDR (proliferative diabetic retinopathy) or regressed PDR
• In patients with bilateral macular edema, only one eye is included in the study.

Exclusion Criteria:

• uncomplicated cataract surgery
• history of cataract surgery during last 4 months
• history of Panretinal Photocoagulation (PRP) during last 4 months
• any retinochoroidal disease except Diabetic retinopathy
• optic disc pathology
• patient with high-risk PDR or advanced PDR
• one-eye patients
• patient with glaucoma or uveitis
• pregnant or lactating patients
• patients whom topical Timolol or Dorzolamide are prohibited for any reason

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide
31 cases in intervention group receive injections of 1.25 mg of intravitreal bevacizumab monthly for 3 months (months 0, 1 and 2) with topical drops of Timolol twice a day and Dorzolamide twice a day
• Injections of 1.25 mg of intravitreal bevacizumab with artificial tears
31 cases in control group receive intravitreal injection of 1.25 mg bevacizumab monthly for 3 months (months 0, 1 and 2) plus artificial tears (twice a day as a placebo)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central macular thickness	Measured by EDI-OCT	1 month
Secondary	Best corrected visual acuity (BCVA)	By ophthalmology resident with subjective and objective refraction	1 month