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Diabetic Macular EdemaPhase 2/3NCT05582577

Additional Effect of Subthreshold Micropulse Laser to Intravitreous Injection of Bevacizumab on Diabetic Macular Edema

A Phase 2/3 study testing Intravitreal bevacizumab injection with subthreshold micropulse laser and Intravitreal bevacizumab injection alone 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B… Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Intravitreal bevacizumab injection with subthreshold micropulse laser and Intravitreal bevacizumab injection alone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteIran
Study dates
15 Oct 2022to 15 Dec 2023
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 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • > 18 years diabetic patients
  • Center-involved diabetic macular edema
  • Mean central subfield thickness >300 micrometers
  • Best-corrected visual acuity between 20/40 and 20/400

Who cannot join

  • hemoglobin A1c > 8
  • High-risk proliferative diabetic retinopathy
  • Prior treatment with intravitreal or peribulbar injections within the preceding 3 months
  • History of panretinal photocoagulation within the former 4 months
  • History of macular photocoagulation
  • Hx of Intraocular surgery (except cataract extraction)
Show all 14Show fewer
  • cataract extraction less than 6 months ago
  • Macular edema due to a cause other than diabetic retinopathy
  • Any other ocular condition that visual acuity would not improve from the resolution of the edema (eg, foveal atrophy)
  • Substantial cataract estimated to have reduced visual acuity by >3 lines
  • uveitis, neovascular glaucoma, exudative age-related macular degeneration, high risk proliferative diabetic retinopathy
  • vitreomacular traction or epiretinal membrane
  • uncontrolled glaucoma ( > 30 millimeters of mercury with anti-glaucoma medications)
  • Not having: Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

Trial locations and contacts

1 site in 1 country.

Iran1 site

  • Ophthalmic Research Center

    Tehran

Other trials in Iran

About this study

Official title: Additional Effect of Sub-threshold Micro-pulse Laser to Intra-vitreous Injection of Bevacizumab on Diabetic Macular Edema: A Randomized Double-blinded Clinical Trial

In this study, all eyes with diabetic macular edema who meet the inclusion criteria and do not meet the exclusion criteria will be included. After the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose.

A subthreshold micropulse laser will be performed after the third injection in group A and a sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns.

The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.

Being tested
Intravitreal bevacizumab injection with subthreshold micropulse laser, Intravitreal bevacizumab injection alone

What participants receive

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

  • Intravitreal bevacizumab injection with subthreshold micropulse laserCombination product

    Group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser

  • Intravitreal bevacizumab injection aloneDrug

    Group B: Intravitreal injection of Bevacizumab alone

Study groups in NCT05582577
Study groupRoleWhat they receive
Simultaneous intravitreal bevacizumab injection with subthreshold micropulse laserExperimentalAfter the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A subthreshold micropulse laser will be performed after the third injection in group A. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Receives: Combination Product: Intravitreal bevacizumab injection with subthreshold micropulse laser
Intravitreal bevacizumab injection aloneActive comparatorAfter the eye examination, the eyes will be randomly divided into 2 groups {group A: intravitreal interjection of Bevacizumab and subthreshold micropulse laser, and group B: intravitreal injection of Bevacizumab alone}. For both groups, 3 intravitreal injections of bevacizumab with a dose of 1.25 mg will be performed, in sterile conditions at 1-month intervals as a loading dose. A sham laser will be performed after the third injection in group B. Then, the intravitreal injection of Bevacizumab will be continued if the central thickness of the macula is equal to or greater than 300 microns. The follow-up will be performed 2, 3, 4, 6, 8, 10, and 12 months after the first injection. In each follow-up (except for the first month), ophthalmological examinations and Optical Coherence Tomography will be performed.
Receives: Drug: Intravitreal bevacizumab injection alone

What is being measured

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

  1. Change from baseline central macular thickness at 2 months

    Change from baseline central macular thickness at 2 months using Optical Coherence Tomography

    Measured: Change from baseline to 2 months

  2. Change from 2 months central macular thickness at 3 months

    Change from 2 months central macular thickness at 3 months using Optical Coherence Tomography

    Measured: Change from 2 months to 3 months

  3. Change from 3 months central macular thickness at 4 months

    Change from 3 months central macular thickness at 4 months using Optical Coherence Tomography

    Measured: Change from 3 months to 4 months

  4. Change from 4 months central macular thickness at 6 months

    Change from 4 months central macular thickness at 6 months using Optical Coherence Tomography

    Measured: Change from 4 months to 6 months

  5. Change from 6 months central macular thickness at 8 months

    Change from 6 months central macular thickness at 8 months using Optical Coherence Tomography

    Measured: Change from 6 months to 8 months

  6. Change from 8 months central macular thickness at 10 months

    Change from 8 months central macular thickness at 10 months using Optical Coherence Tomography

    Measured: Change from 8 months to 10 months

  7. Change from 10 months central macular thickness at 12 months

    Change from 10 months central macular thickness at 12 months using Optical Coherence Tomography

    Measured: Change from 10 months to 12 months

Secondary outcomes (7)

  1. Change from baseline visual acuity at 2 months

    Change from baseline best-corrected visual acuity at 2 months

    Measured: Change from baseline to 2 months

  2. Change from 2 months visual acuity at 3 months

    Change from 2 months best-corrected visual acuity at 3 months

    Measured: Change from 2 months to 3 months

  3. Change from 3 months visual acuity at 4 months

    Change from 3 months best-corrected visual acuity at 4 months

    Measured: Change from 3 months to 4 months

  4. Change from 4 months visual acuity at 6 months

    Change from 4 months best-corrected visual acuity at 6 months

    Measured: Change from 4 months to 6 months

  5. Change from 6 months visual acuity at 8 months

    Change from 6 months best-corrected visual acuity at 8 month

    Measured: Change from 6 months to 8 months

  6. Change from 8 months visual acuity at 10 months

    Change from 8 months best-corrected visual acuity at 10 months

    Measured: Change from 8 months to 10 months

  7. Change from 10 months visual acuity at 12 months

    Change from 10 months best-corrected visual acuity at 12 months

    Measured: Change from 10 months to 12 months

Timeline

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

  1. First posted17 Oct 2022
  2. Study start15 Oct 2022
  3. Primary completion15 Oct 2023 (estimated)
  4. Study completion15 Dec 2023 (estimated)

Resources

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, Investigator
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05582577
Sponsor's protocol ID
14016
Status last verified
Oct 2022
First submitted
10 Sep 2022
Last updated
17 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Intravitreal bevacizumab injection with subthreshold micropulse laser and Intravitreal bevacizumab injection alone in people with Diabetic Macular Edema, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.

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 14 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 17 Oct 2022. 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. 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?

Change from baseline central macular thickness at 2 months (time frame: Change from baseline to 2 months). The study lists 7 primary outcomes in all. 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 NCT05582577.

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 17 Oct 2022.

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