Longitudinal Study of Retinal Function in Eyes Treated for Diabetic Macular Edema With Anti-VEGF Agents (AS)
A considerable hurdle to the development of novel, more effective therapies for diabetic retinal disease is the limited number of primary endpoints available for use in regulatory trials. Current endpoints necessitate long trial durations and a greater number of participants to show efficacy. Thus, a better understanding of the structural and functional changes in the retina occurring in people with diabetes is essential for developing primary endpoints and validating surrogate and clinical endpoints.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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California
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Huntington Beach, California, Forente stater, 92647
- Rekruttering
- Retina Consultants of Southern California
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Ta kontakt med:
- Hani Salehi-Had, MD
- Telefonnummer: 657-227-9496
- E-post: i.gomez@retinasocal.com
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Georgia
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Augusta, Georgia, Forente stater, 30909
- Rekruttering
- Southeast Retina Center, P.C.
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Ta kontakt med:
- Dennis M Marcus, MD
- Telefonnummer: 709-650-0061
- E-post: amitchell@southeastretina.com
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Rekruttering
- Boston Medical Center Corporation
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Ta kontakt med:
- Steven D Ness, MD
- Telefonnummer: 617-414-4020
- E-post: sreevardhan.alluri@bmc.org
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Rekruttering
- Henry Ford Health System
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Ta kontakt med:
- Paul A Edwards, MD
- Telefonnummer: 313-874-9167
- E-post: mdakhil1@hfhs.org
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Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Rekruttering
- Mayo Clinic
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Ta kontakt med:
- Andrew J. Barkmeier, MD
- Telefonnummer: 507-538-8119
- E-post: Taylor.Laura2@mayo.edu
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Pennsylvania
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Monroeville, Pennsylvania, Forente stater, 15146
- Rekruttering
- Retina-Vitreous Consultants, Inc.
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Ta kontakt med:
- Shripaad Y Shukla, MD
- Telefonnummer: 412-683-5300
- E-post: merlottil@retinapittsburgh.com
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Sewickley, Pennsylvania, Forente stater, 15143
- Rekruttering
- Pittsburgh Clinical Trial Consortium
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Ta kontakt med:
- Leanne T. Labriola, DO, MBA
- Telefonnummer: 412-301-5326
- E-post: franco@pghtrials.com
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Texas
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Beaumont, Texas, Forente stater, 77707
- Rekruttering
- Retina Consultants of Texas
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Ta kontakt med:
- William Pearce, MD
- Telefonnummer: 9008335921
- E-post: alaida.jimenez@retinaconsultantstexas.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Key inclusion criteria:
- Age ≥18 years
- Diagnosed with Type 1 or Type 2 diabetes
- Best corrected visual acuity 20/320 or better (Snellen) (≥24 ETDRS letters)
- At least 1 eye with CI-DME requiring treatment
- Able and willing to provide informed consent.
Key exclusion criteria:
- Ocular or systemic condition, aside from diabetes mellitus (DM), that is likely to affect the assessment of DRSS, DME, or the functioning of the neural retina.
- Previous treatment of any kind for diabetic retinopathy or DME
- Any condition that may preclude adequate imaging of the macula (e.g. dense cataract or other media opacity, ptosis)
- History of rhegmatogenous retinal detachment or macular hole
- History of vitrectomy
- Intraocular surgery (including cataract surgery) within 4 months prior to enrollment or anticipated within the next 6 months
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Mild center-involved diabetic macular edema
Eyes with optical coherence tomography central subfield thickness <75 µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Andre navn:
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Aktiv komparator: Moderate Center-involved diabetic macular edema
Eyes with OCT central subfield thickness 75 to <175 µm above DRCR standard thresholds of: Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Andre navn:
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Aktiv komparator: Severe Center-involved diabetic macular edema
Severe CI-DME: Eyes with OCT central subfield thickness >=175µm above DRCR standard thresholds of Zeiss Cirrus central subfield: ≥ 290µm in women or ≥ 305µm in men • Heidelberg Spectralis central subfield: ≥ 305µm in women or ≥ 320µm in men |
All study eyes will receive an injection of anti-VEGF at baseline, 4, and 8 weeks. The participant will then be assessed for treatment every 8 weeks. At and after the 16-week visit, an injection will only be given if the eye has center-involved DME or visual acuity worse than 20/20 (presumed to be due to DME). Otherwise, an injection will not be given. The follow-up interval remains 8 weeks regardless of whether an injection is given or deferred. However, if an injection is deferred and the participant experiences vision issues or other symptoms, they may return for evaluation prior to 8 weeks (e.g., in 4 weeks) and can receive an injection (provided it has been at least 21 days since the last injection).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in multifocal pupillographic objective perimetry (mfPOP) response delays
Tidsramme: Baseline to 1 year
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mfPOP response delays measured using the Objective Field Analyzer (OFA) |
Baseline to 1 year
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Change in area under the log contrast sensitivity function (AULCSF)
Tidsramme: Baseline to 1 year
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AULCSF as measured by the Adaptive Sensory Testing (AST) Manifold contrast sensitivity testing system |
Baseline to 1 year
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Change in electroretinography parameter
Tidsramme: Baseline to 1 year
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Measured by the RETeval device |
Baseline to 1 year
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Change in reading performance
Tidsramme: Baseline to 1 year
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Measured by the MNREAD test |
Baseline to 1 year
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Change in visual field function
Tidsramme: Baseline to 1 year
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Measured by Humphrey Visual Field testing |
Baseline to 1 year
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Change in diabetic retinopathy severity
Tidsramme: Baseline to 1 year
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Assessed by ultra-widefield (UWF) color fundus photography |
Baseline to 1 year
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Change in retinal vascular pathology
Tidsramme: Baseline to 1 year
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Assessed by ultra-widefield fluorescein angiography (UWF-FA) |
Baseline to 1 year
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Change in retinal structure
Tidsramme: Baseline to 1 year
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measured by optical coherence tomography (OCT) |
Baseline to 1 year
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Change in retinal microvascular parameter
Tidsramme: Baseline to 1 year
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Measured by optical coherence tomography angiography (OCTA) |
Baseline to 1 year
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Protocol AS (1)
- UG1EY014231 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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