- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01572350
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)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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-
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Las Palmas de Gran Canaria, Espagne
- Hospital Universitario Dr Negrin
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Bévacizumab
|
Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
Autres noms:
|
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Comparateur actif: Grid laser
It's a reference standard as the treatment which is currently accepted for NTDDME
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Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
|
|
Expérimental: Triamcinolone 4 mg
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Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Best-Corrected Visual Acuity (BCVA)
Délai: 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)
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
To assess the safety of intravitreal Triesence (r)
Délai: 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.
|
Baseline, 3m, 6m and 12 months
|
|
To measure average change in mean central macular thickness in each group.
Délai: Baseline and 3, 6 and 12 months after the treatment was initiated.
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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)
Délai: 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
|
Baseline, 3m, 6m and 12 months
|
|
To assess the safety of intravitreal grid photocoagulation
Délai: 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
|
Baseline, 3m, 6m and 12 months
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Alicia Pareja, MD, Hospital Universitario de Canarias
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies oculaires
- Dégénérescence rétinienne
- Maladies rétiniennes
- Dégénérescence maculaire
- Œdème maculaire
- Œdème
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Bévacizumab
- Triamcinolone
- Acétonide de triamcinolone
- Hexacétonide de triamcinolone
- Diacétate de triamcinolone
Autres numéros d'identification d'étude
- ALBA09
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