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

NCT01572350 | Completed Phase 3

• 1 other identifier: ALBA09
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 plus bevacizumab.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (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)

  12 months

Secondary Outcomes (4)

• To assess the safety of intravitreal Triesence (r)

  Baseline, 3m, 6m and 12 months

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

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

• To assess the safety of intravitreal Avastin (r)

  Baseline, 3m, 6m and 12 months

• To assess the safety of intravitreal grid photocoagulation

  Baseline, 3m, 6m and 12 months

Study Arms (3)

Grid laser

ACTIVE COMPARATOR

It's a reference standard as the treatment which is currently accepted for NTDDME

Other: Grid laser

Triamcinolone 4 mg

EXPERIMENTAL

Drug: Triamcinolone Acetonide

Bevacizumab

EXPERIMENTAL

Drug: Bevacizumab

Interventions

Grid laser OTHER

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

Grid laser

Triamcinolone Acetonide DRUG

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

Also known as: Triesence

Triamcinolone 4 mg

Bevacizumab DRUG

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

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Canarias: lead

Study Sites (1)

Hospital Universitario Dr Negrín

Las Palmas de Gran Canaria, Spain

Location

Related Publications (1)

• 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.

  PMID: 33506177 DERIVED

MeSH Terms

Interventions

Triamcinolone Acetonide; Triamcinolone; Bevacizumab

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Alicia Pareja, MD

  Hospital Universitario de Canarias

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 6, 2012
• Study Start: October 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

ES (1)