Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide
17. september 2019 opdateret af: Unity Health Toronto
Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide: an Interventional Prospective Study
Diabetic macular edema refers to swelling (fluid accumulation) in the center of the retina. The retina is like the film of a camera and is located in the back of the eye. This condition can develop in diabetics where swelling results from leaking of fluid from the blood vessels of the eye, into the center of the retina, the macula. If left untreated, this can affect central vision. The current standard treatment for diabetic macular edema includes medications injected directly into the eye (intravitreal injections) and laser eye treatment. The drugs that are injected directly into the eye are known as anti-Vascular Endothelial Growth Factor (anti-VEGF) agents which help to reduce the leaking. This includes bevacizumab (Avastin®) and ranibizumab (Lucentis®).
However, some patients do not respond well to these anti-VEGF treatments will be given the option of switching to an another class of medications, called steroids. Triamcinolone acetonide is one of these steroids and is also injected directly into the eye. These steroids will help reduce inflammation and possibly as a consequence, reduce swelling in the eye.
The purpose of this study is to determine what cellular factors affect a patient's treatment response (amount of swelling reduction) following triamcinolone acetonide intravitreal injections for diabetic macular edema.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
3
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Ontario
-
Toronto, Ontario, Canada, M5C2T2
- St. Michael's Hospital Eye Clinic
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Presence of Non Proliferative Diabetic Retinopathy (NDPR) or Proliferative Diabetic Retinopathy as confirmed by IntraVenous Fluorescein Angiography (IVFA)
- Prior treatment with ≥ 6 intravitreal anti-VEGF injections but no treatment in last 4 weeks
- Less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline
- Less than 10% reduction in macular volume
- Age 18 years or older
- Subjects with Type I or II diabetes mellitus
- snellen Acuity 20/40 to 20/400 and its ETDRS equivalent
- Ability to provide signed informed consent
- Capable of complying with study protocol.
Exclusion Criteria:
- Previous intraocular injection of steroid medication.
- Concurrent ocular disease (wet Age-Related Macular Degeneration, significant Epiretinal Membrane, vitreomacular traction etc) that would limit visual acuity in the opinion of the treating physician
- Proliferative diabetic retinopathy in the study eye or PanRetinal Photocoagulation within the last 12 months
- Poor glycemic control HbA1c >9%
- Prior vitrectomy surgery.
- Prior intraocular surgery within 3 months in study eye
- Laser treatment within 3 months of study eye
- Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to study enrollment.
- Known history of Intraocular Pressure (IOP) elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm Hg increase in IOP in response to steroid injection, or b) IOP = 25 mm Hg and required 2 or more anti-glaucoma medications to keep IOP below 21 mm Hg.
- Known allergies to study drug or fluorescein
- History of stroke or acute Myocardial Infarction within 6 months of enrolment
- Patients receiving dialysis for renal failure
- Patients currently on systemic immunosuppression
- Patients with glaucoma
- Patients who are pregnant.
- Unwilling or unable to follow or comply with all study related procedures
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Andet: Triamcinolone Acetonide Treatment
Triamcinolone Acetonide Injectable Suspension 40 mg/mL intravitreal injection
|
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in cytokine levels (picograms per mL) between baseline triamcinolone acetonide injection and 3 months
Tidsramme: 3 months after baseline triamcinolone acetonide injection
|
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
|
3 months after baseline triamcinolone acetonide injection
|
|
Change in cytokine levels (picograms per mL) 3 months after 2nd triamcinolone acetonide injection
Tidsramme: 3 months after 2nd triamcinolone acetonide injection
|
Note that the 2nd triamcinolone acetonide injection occurs 3 months after baseline injection.
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
|
3 months after 2nd triamcinolone acetonide injection
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
Tidsramme: 3 months after baseline injection
|
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Change in ETDRS BCVA is in ETDRS letters.
|
3 months after baseline injection
|
|
Change in ocular cytokine levels (picograms per mL) in relation to change in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) in response to steroid treatment
Tidsramme: 3 months after 2nd triamcinolone acetonide injection
|
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Change in ETDRS BCVA is in ETDRS letters.
|
3 months after 2nd triamcinolone acetonide injection
|
|
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
Tidsramme: 3 months after baseline injection
|
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Change in CMT is in micrometers (um).
|
3 months after baseline injection
|
|
Change in ocular cytokine levels (picograms per mL) in relation to change in central macular thickness (CMT) measured in micrometers (um) from optical coherence tomography
Tidsramme: 3 months after 2nd triamcinolone acetonide injection
|
The study involves the measurement of ocular cytokines in the anterior chamber fluid including: EGF, VEGF, PlGF, IL-2, IL-3, IL-6, IL-17, TGF-B2, IL-8, VCAM, TGF-B, MMP-9, MIG, ICAM-1 and MCP-1.
Change in CMT is in micrometers (um).
|
3 months after 2nd triamcinolone acetonide injection
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Rajeev Muni, MD MSc FRCSC, Unity Health Toronto
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2015
Primær færdiggørelse (Faktiske)
1. december 2016
Studieafslutning (Faktiske)
1. december 2016
Datoer for studieregistrering
Først indsendt
18. august 2014
Først indsendt, der opfyldte QC-kriterier
18. august 2014
Først opslået (Skøn)
20. august 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. september 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2019
Sidst verificeret
1. september 2019
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
- Immunsuppressive midler
- Immunologiske faktorer
- Glukokortikoider
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Triamcinolon
- Triamcinolonacetonid
- Triamcinolonhexacetonid
- Triamcinolondiacetat
Andre undersøgelses-id-numre
- PersDMEcytokineTA
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 .