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.
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:
- Age ≥18 years from both sexes. Women of childbearing age should use adequate contraception methods and submit a negative pregnancy test.
- 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).
- Patient able to give informed consent.
- Eye with clear media, pupil dilation and patient able to cooperate to perform retinography, OCT and fluorescein angiography.
- 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.
- Patients with diffuse diabetic macular edema.
- Patients with not tractional diabetic macular edema.
A patient is not eligible if any of the following exclusion criteria are present:
- Women of childbearing age not using adequate contraceptive methods.
- Pregnancy and lactation. Pregnancy test was performed before starting treatment.
- Chronic renal failure requiring dialysis or kidney transplantation.
- Allergy to any of the drugs included in the study.
- Systemic use of steroids in the last 4 months.
- Patient intends to change his place of residence within 3 years after recruitment, whenever you go to an area not covered by the study.
- Blood pressure>180/110. If blood pressure is brought below 180/110 by anti-hypertensive treatment, patient can become eligible.
- HbA1c> 11% in the current analysis or done in the last 2 months.
- 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).
- 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.)
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more
- History of prior treatment with intravitreal corticosteroids or intravitreal antiangiogenic.
- History of peribulbar steroid injection within 6 months prior to randomization.
- History of focal, grid or panretinal photocoagulation within 4 months prior to randomization.
- Need of panretinal photocoagulation in the first 4 months of treatment.
- History of prior pars plana vitrectomy.
- Major ocular surgery (including cataract extraction, scleral buckle, vitrectomy, etc.) within prior 6 months or anticipated within the next 6 months following randomization.
- History of YAG capsulotomy performed within 2 months prior to randomization.
- Intraocular pressure >25mmHg.
- 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.
- History of cortisone-induced glaucoma that required IOP-lowering treatment.
- History of prior herpetic ocular infection.
- Exam evidence of ocular toxoplasmosis.
- Aphakia.
- Presence of pseudoexfoliation.
- Evidence of external ocular infection, including: conjunctivitis, chalazion and blepharitis.
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Diabetic Macular Edema
- 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 group | Role | What they receive |
|---|---|---|
| Grid laser | Active comparator | It's a reference standard as the treatment which is currently accepted for NTDDME Receives: Other: Grid laser |
| Triamcinolone 4 mg | Experimental | Not described Receives: Drug: Triamcinolone Acetonide |
| Bevacizumab | Experimental | Not described Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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.
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
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.
- First posted6 Apr 2012 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionDec 2013
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Pareja, MD, Principal investigator, Hospital Universitario de Canarias
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01572350
- Acronym / sponsor ID
- ALBA / ALBA09
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- Oct 2010 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Apr 2012 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Grid laser | Active comparator | Other: Grid laserIt's a reference standard as the treatment which is currently accepted for NTDDME |
| Triamcinolone 4 mg | Experimental | Drug: Triamcinolone Acetonide |
| Bevacizumab | Experimental | Drug: Bevacizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Grid laserGrid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT. | Other | Grid laser |
| Triamcinolone AcetonideAlso: TriesenceTriamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks | Drug | Triamcinolone 4 mg |
| BevacizumabAlso: AvastinBevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks | Drug | Bevacizumab |
Primary outcome
Best-Corrected Visual Acuity (BCVA)
Time frame: 12 months
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)
4 secondary outcomes
To assess the safety of intravitreal Triesence (r)
Time frame: Baseline, 3m, 6m and 12 months
To measure average change in mean central macular thickness in each group.
Time frame: Baseline and 3, 6 and 12 months after the treatment was initiated.
To assess the safety of intravitreal Avastin (r)
Time frame: Baseline, 3m, 6m and 12 months
To assess the safety of intravitreal grid photocoagulation
Time frame: Baseline, 3m, 6m and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Derived from this study: PubMed 33506177Pareja-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.
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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.
Alicia Pareja, MD principal investigator
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
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.