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

NCT ID: NCT05083689

Last Updated: 2021-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-06

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Injections of 1.25 mg of intravitreal bevacizumab with topical drops of 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

Group Type ACTIVE_COMPARATOR

Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide

Intervention Type 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 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)

Group Type PLACEBO_COMPARATOR

Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

Intervention Type 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)

Interventions

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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

Intervention Type DRUG

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)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 38376643 (View on PubMed)

Other Identifiers

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14002

Identifier Type: -

Identifier Source: org_study_id