Diabetic Macular EdemaPhase 2/3NCT05083689

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

A Phase 2/3 study testing Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide and Injections of 1.25 mg of intravitreal bevacizumab with artificial tears in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide and Injections of 1.25 mg of intravitreal bevacizumab with artificial tears
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 1 siteIran
Study dates: 6 Oct 2021to Apr 2022
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

one-eye patients
patient with glaucoma or uveitis
pregnant or lactating patients
patients whom topical Timolol or Dorzolamide are prohibited for any reason

Trial locations and contacts

1 site in 1 country.

Iran1 site

Ophthalmic Research Center
Tehran

Other trials in Iran

About this study

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
Being tested: Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide, Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Injections of 1.25 mg of intravitreal bevacizumab with Timolol and DorzolamideDrug
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 tearsDrug
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)

Study groups in NCT05083689
Study group	Role	What they receive
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 Receives: 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) Receives: Drug: Injections of 1.25 mg of intravitreal bevacizumab with artificial tears

What is being measured

The primary outcome is the main question the study is designed to answer.

Central macular thickness
Measured by EDI-OCT
Measured: 1 month

Secondary outcomes (1)

Best corrected visual acuity (BCVA)
By ophthalmology resident with subjective and objective refraction
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Oct 2021Apr 2022

First posted19 Oct 2021
Study start6 Oct 2021
Primary completionMar 2022 (estimated)
Study completionApr 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 62 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05083689
Sponsor's protocol ID: 14002
Status last verified: Oct 2021
First submitted: 6 Oct 2021
Last updated: 19 Oct 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 38376643

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Intravitreal Bevacizumab With Topical Timolol-Dorzolamide Eye Drops in Diabetic Macular Edema
ClinicalTrials.gov ID: NCT05083689
Acronym / sponsor ID: 14002
Conditions: Diabetic Macular Edema
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 62 participants (estimated)
Lead sponsor: Shahid Beheshti University of Medical SciencesUniversity, hospital or other
Study start: 6 Oct 2021 (actual)
Primary completion: Mar 2022 (estimated)
Study completion: Apr 2022 (estimated)
First posted: 19 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Injections of 1.25 mg of intravitreal bevacizumab with topical drops of Timolol and Dorzolamide	Active comparator	Drug: Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide31 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	Placebo comparator	Drug: Injections of 1.25 mg of intravitreal bevacizumab with artificial tears31 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)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Injections of 1.25 mg of intravitreal bevacizumab with Timolol and Dorzolamide31 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 topical drops of Timolol and Dorzolamide
Injections of 1.25 mg of intravitreal bevacizumab with artificial tears31 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

Primary outcome

Central macular thickness
Time frame: 1 month
Measured by EDI-OCT

1 secondary outcome

Best corrected visual acuity (BCVA)
Time frame: 1 month

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Derived from this study: PubMed 38376643Fekri 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.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central macular thickness (time frame: 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05083689, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.