AzTrials
AzTrials

Diabetic Macular EdemaPhase 3ALBANCT01572350

Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema

A Phase 3 study testing Grid laser, Triamcinolone Acetonide and Bevacizumab in people with Diabetic Macular Edema, run by Hospital Universitario de Canarias at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Grid laser, Triamcinolone Acetonide and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteSpain
Study dates
Oct 2010to Dec 2013
Phase
Phase 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
  • No healthy volunteers
  • Adult, Older adult

To be eligible, the following inclusion criteria must be met:

  1. Age ≥18 years from both sexes. Women of childbearing age should use adequate contraception methods and submit a negative pregnancy test.
  2. Diagnosis of diabetes mellitus type 1 or type 2 (documented by ADA or WHO guidelines) and serum HbA1c <11% at the time of randomization (determinations done in the last two months).
  3. Patient able to give informed consent.
  4. Eye with clear media, pupil dilation and patient able to cooperate to perform retinography, OCT and fluorescein angiography.
  5. Patients with clinically significant diabetic macular edema; the patient must have at least one: 5.1) retinal thickening within 500 μ from the center or 5.2) hard exudates within 500 μ from the center if associated with adjacent retinal thickening or 5.3) the size of retinal thickening at least 1 area disc, part of which is less than 1 DD of the center.
  6. Patients with diffuse diabetic macular edema.
  7. Patients with not tractional diabetic macular edema.

A patient is not eligible if any of the following exclusion criteria are present:

  1. Women of childbearing age not using adequate contraceptive methods.
  2. Pregnancy and lactation. Pregnancy test was performed before starting treatment.
  3. Chronic renal failure requiring dialysis or kidney transplantation.
  4. Allergy to any of the drugs included in the study.
  5. Systemic use of steroids in the last 4 months.
  6. Patient intends to change his place of residence within 3 years after recruitment, whenever you go to an area not covered by the study.
  7. Blood pressure>180/110. If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
  8. HbA1c> 11% in the current analysis or done in the last 2 months.
  9. An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hare exudates, nonretinal condition).
  10. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, etc.)
  11. Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
  12. History of prior treatment with intravitreal corticosteroids or intravitreal antiangiogenic.
  13. History of peribulbar steroid injection within 6 months prior to randomization.
  14. History of focal, grid or panretinal photocoagulation within 4 months prior to randomization.
  15. Need of panretinal photocoagulation in the first 4 months of treatment.
  16. History of prior pars plana vitrectomy.
  17. Major ocular surgery (including cataract extraction, scleral buckle, vitrectomy, etc.) within prior 6 months or anticipated within the next 6 months following randomization.
  18. History of YAG capsulotomy performed within 2 months prior to randomization.
  19. Intraocular pressure >25mmHg.
  20. History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion). A history of ocular hypertension is not an exclusion as long as (1) intraocular pressure is <25 mmHg, (2) the patient is using no more than one topical glaucoma medication, (3) the most recent visual field, performed within the last 12 months, is normal (if abnormalities are present on the visual field they must be attributable to the patient's diabetic retinopathy), and (4) the optic disc does not appear glaucomatous.
  21. History of cortisone-induced glaucoma that required IOP-lowering treatment.
  22. History of prior herpetic ocular infection.
  23. Exam evidence of ocular toxoplasmosis.
  24. Aphakia.
  25. Presence of pseudoexfoliation.
  26. Evidence of external ocular infection, including: conjunctivitis, chalazion and blepharitis.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital Universitario Dr Negrín

    Las Palmas de Gran Canaria

Other trials in Spain

About this study

Official title: Randomized Multicenter Clinical Trial of Three Parallel Groups to Estimate the Safety and Efficacy of Triamcinolone Acetonide Combined With Laser, Bevacizumab Combined With Laser Versus Laser Alone for the Treatment of Diffuse Non-tractional Diabetic Macular Edema.

This clinical trial is designed to investigate differences in terms of efficacy (mean change in best corrected visual acuity obtained after 12 months of treatment) and safety, of 3 therapeutic estrategies for non-tractional macular edema in diabetic patients: a) laser alone; b) laser plus tiramcinolon; and c) laser plus bevacizumab.

Being tested
Grid laser, Triamcinolone Acetonide, Bevacizumab

What participants receive

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

  • Grid laserOther

    Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.

  • Triamcinolone AcetonideDrug

    Also called Triesence

    Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks

Study groups in NCT01572350
Study groupRoleWhat they receive
Grid laserActive comparatorIt's a reference standard as the treatment which is currently accepted for NTDDME
Receives: Other: Grid laser
Triamcinolone 4 mgExperimentalNot described
Receives: Drug: Triamcinolone Acetonide
BevacizumabExperimentalNot described
Receives: Drug: Bevacizumab

What is being measured

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

  1. Best-Corrected Visual Acuity (BCVA)

    To evaluate the effect on best-corrected visual acuity (BCVA) of intravitreal triamcinolone (Triesence ®) or bevacizumab (Avastin ®) in combination with grid laser therapy compared to grid laser therapy alone after 12 months of treatment, in diabetic patients with not tractional diffuse macular edema (NTDDEM)

    Measured: 12 months

Secondary outcomes (4)
  1. To assess the safety of intravitreal Triesence (r)

    Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability.

    Measured: Baseline, 3m, 6m and 12 months

  2. To measure average change in mean central macular thickness in each group.

    To measure average change in mean central macular thickness (in microns) obtained by Optical Coherence Tomography (OCT) at each follow-up visits compared to the baseline visit in each of the three groups.

    Measured: Baseline and 3, 6 and 12 months after the treatment was initiated.

  3. To assess the safety of intravitreal Avastin (r)

    Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Baseline, 3m, 6m and 12 months

  4. To assess the safety of intravitreal grid photocoagulation

    Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Measured: Baseline, 3m, 6m and 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 posted6 Apr 2012 (estimated)
  2. Study startOct 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01572350
Sponsor's protocol ID
ALBA09
Acronym
ALBA
Status last verified
Feb 2021
First submitted
7 Apr 2011
Last updated
15 Feb 2021
Results posted
No

Publications

  • Pareja-Rios A, de Armas-Ramos E, Aldea-Perona A, Bonaque-Gonzalez S. Alone laser versus bevacizumab plus laser for diffuse diabetic macular edema (ALBA randomized trial). Ther Adv Ophthalmol. 2021 Jan 15;13:2515841420988210. doi: 10.1177/2515841420988210. eCollection 2021 Jan-Dec.

    PubMed 33506177

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Grid laser, Triamcinolone Acetonide and Bevacizumab in people with Diabetic Macular Edema, run by Hospital Universitario de Canarias at 1 site in Spain.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 15 Feb 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 Spain. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Best-Corrected Visual Acuity (BCVA) (time frame: 12 months). 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 NCT01572350, 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 15 Feb 2021.

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