Clinical trial NCT05083689: Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema
Official title: Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Central macular thickness
timeFrame: 1 month
Secondary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 1 month
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
References: