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 recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Hospital Universitario de Canarias.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario de Canarias
ClinicalTrials.gov Identifier:
NCT01572350
First received: April 7, 2011
Last updated: April 4, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Other: Grid laser
Drug: Triamcinolone Acetonide
Drug: Bevacizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario de Canarias:

Primary Outcome Measures:
  • Best-Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • To assess the safety of intravitreal Triesence (r) [ Time Frame: Baseline, 3m, 6m and 12 months ] [ Designated as safety issue: Yes ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability


Estimated Enrollment: 105
Study Start Date: October 2010
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572350

Contacts
Contact: Alicia Pareja, MD +34 922 679678 aparejar@gmail.com

Locations
Spain
Hospital Universitario Dr Negrín Recruiting
Las Palmas de Gran Canaria, Spain
Principal Investigator: MªDolores Marrero, MD         
Complejo Hospitalario Materno Infantil Insular Recruiting
Las Palmas de Gran Canaria, Spain
Principal Investigator: Francisco Cabrera, MD         
Hospital Universitario de Nuestra Sra de Candelaria Recruiting
Santa Cruz de Tenerife, Spain
Contact    +34 922 679678      
Principal Investigator: Rodrigo Abreu, MD         
Sponsors and Collaborators
Hospital Universitario de Canarias
Investigators
Principal Investigator: Alicia Pareja, MD Hospital Universitario de Canarias
  More Information

No publications provided

Responsible Party: Hospital Universitario de Canarias
ClinicalTrials.gov Identifier: NCT01572350     History of Changes
Other Study ID Numbers: ALBA09
Study First Received: April 7, 2011
Last Updated: April 4, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 24, 2014