Triple Therapy for Diffuse Diabetic Macular Edema (TTDDME)
18. oktober 2010 oppdatert av: Military Institute of Medicine, Poland
Combined Phako-Vitrectomy With ILM Peeling, Retinal Endophotocoagulation, and Intraoperative Use of Bevacizumab for Diffuse Diabetic Macular Edema
The purpose of this study is to evaluate the safety end efficacy of combined phakoemulsification and vitrectomy with retinal endophotocoagulation and intraoperative use of bevacizumab in patients with diffuse diabetic macular edema (DDME), to determine the possible preoperative and intraoperative factors that might influence surgical outcomes.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The pathogenesis of the diabetic macular edema is multiple. Therefore treatment of this disease should be combined too. VEGF is involved in pathogenesis of diabetic macular edema and recently anti-VEGF agents such as bevacizumab have been shown to be beneficial in the treatment of this retinal disorder. However, endogenous VEGF is required for visual function. Growing body evidence indicates that VEGF acts also on nonvascular cells, it plays survival role on Muller cells and photoreceptors. Therefore anti-VEGF therapies should be administered with caution and not persistent. Photocoagulation in nonperfused areas eliminate increased production of VEGF, proliferation of RPE and increased production of PEDF in surrounded impact laser area. Vitrectomy with ILM peeling reliefs traction on the macula, improve oxygenation of the macula leading to decreased vascular permeability with subsequent resolution or decrease in DME. Removed ILM contains a part of the Müller cell endfeet and the horizontal gliosis. It is likely that the proliferation of GFAP-stained gliofibrils, observed in microdamaged Müller cells, preserves the blood-retinal barrier, reinforces architectural cohesion, and opposes the installation of the edema. Therefore, we made hypothesis that combined triple therapy was effective for decreasing macular thickness and improvement of vision for eyes with diffuse diabetic macular edema.
It is important for the surgeon to determine the factors that might influence surgical outcome so that patients are chosen for the procedure that they can get benefit from. Therefore, we evaluated the possible preoperative and intraoperative factors that might influence surgical outcomes
Studietype
Intervensjonell
Registrering (Forventet)
30
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Robaszkiewicz Jacek, dr med.
- Telefonnummer: +48604597970
- E-post: vectra@izet.pl
Studer Kontakt Backup
- Navn: Chmielewska Katarzyna, lek.med.
- Telefonnummer: +48509142510
- E-post: kchmielewska@interia.pl
Studiesteder
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Szaserów 44
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Warsaw, Szaserów 44, Polen, 04-141
- Rekruttering
- Military Institute of Medicine
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Hovedetterforsker:
- Robaszkiewicz Jacek, dr med.
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Underetterforsker:
- Chmielewska I. Katarzyna, lek. med.
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Ta kontakt med:
- Kowal Ewelina
- Telefonnummer: (+48) 22 665 707 584
- E-post: ekowal@wim.mil.pl
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- diagnosis of DDME on clinical exam, definite retinal thickening involving the center of the macula, confirmed by fluorescein angiography, with or without PVD,
- BCVA of 0,3 or worse in log MAR units (<=70 ETDRS letter) and 1,5 or better in log MAR units (>=10 ETRDS letter),
- mean central macular thickness greater than 250 μm on optic coherence tomography (OCT),
- presence of vitreomacular traction or a thickened and taut posterior hyaloid or presence of an epimacular membrane.
Exclusion Criteria:
- significant macular ischemia defined as enlarged perifoveal capillary loss (>1000 µm) by fluorescein angiography,
- the focal macular edema due to focal leakage from microaneurysm,
- ophthalmic disorders associated with macular edema, such as uveitis, branch or central retinal vein occlusion and pseudophakic cystoid macular edema,
- vitreous hemorrhage or tractional retinal detachment secondary to diabetic retinopathy,
- an ocular condition is present such that, visual acuity would not improve from resolution of macular edema (e.g., foveal atrophy, pigmentary abnormalities, dense subfoveal hard exudates),
- history of retinal macular photocoagulation, intravitreal corticosteroids, or other treatment for DME within 3 months prior to enrollment,
- history of any intraocular surgery within prior 6 months.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: edematous tractional epimacular membrane
Diabatic maculopathy comes to the edematous or tractional form.
It is believed that epiretinal membranes are comprised from glial components.
The processes of these cells may invade through the internal limiting membrane of the retina to the vitreous causing the vitreoretinal adhesion and anomalous posterior detachment of vitreous (APVD).
In the macula, APVD causes vitreo-macular traction syndrome, which results in diffuse diabetic macular edema.
If vitreoschisis is present, a place of dissection is crucial.
If break occurs in front of the hyalocytes remaining on the retinal surface, the vitreous layer is thick and easily shrinks concentrically, which results in the formation of epimacular membrane.
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Three port pars plana vitrectomy is performed by one surgeon (JR).
Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally.
Peeling of the epimacular tissue and ILM is performed by grasping the flap of the ILM with an eckhardts forceps.
Trypan Blue is used to stain the ILM.
Peripheral laser endophotocoagulation is performed in cases of avascular areas based on FA, active neovascularization, peripheral retinoschisis or retinal breaks.
All eyes have a 1,25 mg/0,05 ml bevacizumab injection into vitreous cavity and SF6 gas tamponade at the end of the procedure.
Even of absence of cataract formation, a combined procedure is performed because of exactly peripheral vitreous shaving and prevention of cataract formation.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Tidsramme: up to 1 week before surgery
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The best corrected visual acuity (BCVA) for ETDRS chart and central macular thickness (CMT) are assessed preoperatively and during the follow-up period.
OCT is performed 1 mm and 6 mm diameter topography centered at the patient fixation point.
We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
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up to 1 week before surgery
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Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Tidsramme: 16 up to 17 weeks after surgery
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The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis.
The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO.
We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
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16 up to 17 weeks after surgery
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Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Tidsramme: 32 up to 33 weeks after surgery
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A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis.
The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO.
We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
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32 up to 33 weeks after surgery
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Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Tidsramme: 48 up to 49 weeks after surgery
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A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis.
The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO.
We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
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48 up to 49 weeks after surgery
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Best-corrected visual acuity (BCVA) and central macular thickness (CMT)
Tidsramme: 64 up to 65 weeks after surgery
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A follow-up examination include: The best corrected visual acuity (BCVA) for ETDRS chart, results are converted to log MAR for statistical analysis.
The central macular thickness (CMT) are assessed 1 mm diameter topography centered at the patient fixation point for OCT-SLO.
We evaluate mean central retinal thickness and central retinal volume 1 mm and 6 mm in diameter.
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64 up to 65 weeks after surgery
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Presence of vitreomacular traction or epimacular membrane, grade of DR, patients age, HbA1c level, BMI, systemic hypertension
Tidsramme: up to 2 weeks before surgery
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The demographic characteristics of the patients including: age, grender, metabolic condition: HbA1c level, body mass index, presence of systemic hypertension, ocular condition: diabetic retinopathy stage, previous laser, presence of viteomacular traction or epiretinal membrane are recorded to eveluate the possible association with chance in postoperative BCVA.
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up to 2 weeks before surgery
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Robaszkiewicz Jacek, dr med., Department of Ophthalmology Military Institute of Medicine
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2008
Primær fullføring (Forventet)
1. desember 2010
Studiet fullført (Forventet)
1. desember 2011
Datoer for studieregistrering
Først innsendt
6. oktober 2010
Først innsendt som oppfylte QC-kriteriene
8. oktober 2010
Først lagt ut (Anslag)
11. oktober 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
19. oktober 2010
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. oktober 2010
Sist bekreftet
1. september 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 46/WIM/2008
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