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 (ALBA)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01572350 |
Recruitment Status :
Completed
First Posted : April 6, 2012
Last Update Posted : February 15, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Macular Edema | Other: Grid laser Drug: Triamcinolone Acetonide Drug: Bevacizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 105 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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. |
Actual Study Start Date : | October 2010 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Grid laser
It's a reference standard as the treatment which is currently accepted for NTDDME
|
Other: Grid laser
Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT. |
Experimental: Triamcinolone 4 mg |
Drug: Triamcinolone Acetonide
Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
Other Name: Triesence |
Experimental: Bevacizumab |
Drug: Bevacizumab
Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
Other Name: Avastin |
- 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)
- To assess the safety of intravitreal Triesence (r) [ Time Frame: Baseline, 3m, 6m and 12 months ]Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability.
- 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 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.
- To assess the safety of intravitreal Avastin (r) [ Time Frame: Baseline, 3m, 6m and 12 months ]Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
- To assess the safety of intravitreal grid photocoagulation [ Time Frame: Baseline, 3m, 6m and 12 months ]Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572350
Spain | |
Hospital Universitario Dr Negrín | |
Las Palmas de Gran Canaria, Spain |
Principal Investigator: | Alicia Pareja, MD | Hospital Universitario de Canarias |
Responsible Party: | Hospital Universitario de Canarias |
ClinicalTrials.gov Identifier: | NCT01572350 |
Other Study ID Numbers: |
ALBA09 |
First Posted: | April 6, 2012 Key Record Dates |
Last Update Posted: | February 15, 2021 |
Last Verified: | February 2021 |
Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Bevacizumab Triamcinolone diacetate Antineoplastic Agents, Immunological Antineoplastic Agents |
Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |