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

NCT05083689 | Unknown Phase 2

• 1 other identifier: 14002
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Central macular thickness

  Measured by EDI-OCT

  1 month

Secondary Outcomes (1)

• Best corrected visual acuity (BCVA)

  1 month

Study Arms (2)

Injections of 1.25 mg of intravitreal bevacizumab with topical drops of Timolol and Dorzolamide

ACTIVE COMPARATOR

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

Drug: Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide

Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

PLACEBO COMPARATOR

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)

Drug: Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

Interventions

Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide DRUG

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 topical drops of Timolol and Dorzolamide

Injections of 1.25 mg of intravitreal bevacizumab with artificial tears DRUG

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)

Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

Location

Related Publications (1)

• Fekri S, Rabiei A, Hooshmandi S, Nouri H, Abtahi SH. The effect of combination therapy with intravitreal bevacizumab and topical timolol-dorzolamide eye drops on diabetic macular edema: a double-blind randomized controlled trial. Int Ophthalmol. 2024 Feb 20;44(1):101. doi: 10.1007/s10792-024-03005-z.

  PMID: 38376643 DERIVED

MeSH Terms

Interventions

Timolol; dorzolamide; Lubricant Eye Drops

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophthalmic research center

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: October 6, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

IR (1)