- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Las Palmas de Gran Canaria, Spagna
- Hospital Universitario Dr Negrin
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Bevacizumab
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Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
Altri nomi:
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Comparatore attivo: 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.
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Sperimentale: Triamcinolone 4 mg
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Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Best-Corrected Visual Acuity (BCVA)
Lasso di tempo: 12 months
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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)
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12 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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To assess the safety of intravitreal Triesence (r)
Lasso di tempo: Baseline, 3m, 6m and 12 months
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Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability.
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Baseline, 3m, 6m and 12 months
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To measure average change in mean central macular thickness in each group.
Lasso di tempo: 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.
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Baseline and 3, 6 and 12 months after the treatment was initiated.
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To assess the safety of intravitreal Avastin (r)
Lasso di tempo: Baseline, 3m, 6m and 12 months
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Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Baseline, 3m, 6m and 12 months
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To assess the safety of intravitreal grid photocoagulation
Lasso di tempo: Baseline, 3m, 6m and 12 months
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Type of adverse events, severity and number of Participants with Adverse Events as a Measure of Safety and Tolerability
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Baseline, 3m, 6m and 12 months
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Alicia Pareja, MD, Hospital Universitario de Canarias
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie degli occhi
- Degenerazione retinica
- Malattie retiniche
- Degenerazione maculare
- Edema maculare
- Edema
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Inibitori enzimatici
- Agenti antinfiammatori
- Agenti antineoplastici
- Agenti immunosoppressivi
- Fattori immunologici
- Glucocorticoidi
- Ormoni
- Ormoni, sostituti ormonali e antagonisti ormonali
- Agenti antineoplastici, immunologici
- Inibitori dell'angiogenesi
- Agenti di modulazione dell'angiogenesi
- Sostanze per la crescita
- Inibitori della crescita
- Bevacizumab
- Triamcinolone
- Triamcinolone acetonide
- Triamcinolone esacetonide
- Triamcinolone diacetato
Altri numeri di identificazione dello studio
- ALBA09
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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