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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grid laser | Active Comparator | It's a reference standard as the treatment which is currently accepted for NTDDME |
|
| Triamcinolone 4 mg | Experimental |
| |
| Bevacizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grid laser | Other | Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3m, 6m and 12 months |
| To measure average change in mean central macular thickness in each group. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Alicia Pareja, MD | Hospital Universitario de Canarias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Dr NegrÃn | Las Palmas de Gran Canaria | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33506177 | Derived | 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. |
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| Triamcinolone Acetonide | Drug | Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks |
|
|
| Bevacizumab | Drug | Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks |
|
|
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. |
| 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 | 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 | Baseline, 3m, 6m and 12 months |
| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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