- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
-
Las Palmas de Gran Canaria, Spanien
- Hospital Universitario Dr Negrin
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bevacizumab
|
Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
Andre navne:
|
|
Aktiv komparator: Grid laser
It's a reference standard as the treatment which is currently accepted for NTDDME
|
Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
|
|
Eksperimentel: Triamcinolone 4 mg
|
Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Best-Corrected Visual Acuity (BCVA)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
To assess the safety of intravitreal Triesence (r)
Tidsramme: 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.
Tidsramme: Baseline and 3, 6 and 12 months after the treatment was initiated.
|
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)
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Alicia Pareja, MD, Hospital Universitario de Canarias
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Øjensygdomme
- Nethindedegeneration
- Nethindesygdomme
- Makuladegeneration
- Makulaødem
- Ødem
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Anti-inflammatoriske midler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
- Triamcinolon
- Triamcinolonacetonid
- Triamcinolonhexacetonid
- Triamcinolondiacetat
Andre undersøgelses-id-numre
- ALBA09
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Diabetisk makulært ødem
-
The Lowy Medical Research Institute LimitedUkendtMacula Pigment | Macular TeleangiectasiaTyskland
-
The Lowy Medical Research Institute LimitedIkke rekrutterer endnuMacular Telangiectasia Type 2 (MacTel)Australien, Forenede Stater, Det Forenede Kongerige, Tyskland, Holland
-
Carl Zeiss Meditec, Inc.DataMed Devices Inc.AfsluttetTør AMD Med Macular DrusenForenede Stater
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedAfsluttetMacular Telangiectasia Type 2Forenede Stater, Tyskland, Australien
-
The Lowy Medical Research Institute LimitedAktiv, ikke rekrutterendeMacular Telangiectasia Type 2Forenede Stater, Det Forenede Kongerige
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedAfsluttetMacular Telangiectasia Type 2Forenede Stater, Australien
-
Neurotech PharmaceuticalsThe Emmes Company, LLC; The Lowy Medical Research Institute LimitedAfsluttetMacular Telangiectasia Type 2Forenede Stater, Australien
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedAfsluttetMacular Telangiectasia Type 2 (MacTel)Det Forenede Kongerige, Forenede Stater, Frankrig, Australien
-
Neurotech PharmaceuticalsAktiv, ikke rekrutterendeMacular Telangiectasia Type 2Forenede Stater
-
Neurotech PharmaceuticalsRekrutteringMacular Telangiectasia Type 2 (MacTel)Forenede Stater, Australien
Kliniske forsøg med Grid laser
-
Almirall, S.A.Afsluttet
-
Almirall, S.A.Afsluttet
-
Almirall, S.A.Afsluttet
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Aktiv, ikke rekrutterendeMelanom | SarkomForenede Stater
-
UNC Lineberger Comprehensive Cancer CenterRadiation Oncology InstituteRekruttering
-
University of ArkansasAfsluttetStrålingstoksicitet | Osteosarkom hos børnForenede Stater
-
Washington University School of MedicineRekrutteringPalliativ rumlig fraktioneret (GRID) strålebehandling ved hjælp af intensitetsmoduleret protonterapiMetastatisk kræft | Ikke-operabel fast tumorForenede Stater
-
Washington University School of MedicineRobert Wood Johnson FoundationAfsluttet
-
Sir Mortimer B. Davis - Jewish General HospitalRekrutteringPatienter med symptomatiske eller omfangsrige tumorer (mere end 8 cm) eller med tumorer, der er resistente over for strålingCanada
-
Dartmouth-Hitchcock Medical CenterPatient-Centered Outcomes Research Institute; Mayo Clinic; Montefiore Medical... og andre samarbejdspartnereAfsluttet