A Study to Determine the Safety and Efficacy of NT-501 With M-CHFM
A Multicenter Study to Determine the Safety and Efficacy of NT-501 Utilizing the Medica Membrane in Macular Telangiectasia Type 2 (MacTel), Including a Randomized Comparative Expansion Cohort
The overall purpose of this global, multicenter, two cohort, central image evaluator masked study is to characterize the clinical safety and efficacy of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM) for the treatment of MacTel and to evaluate whether its safety profile and efficacy are comparable to those of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM).
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This Phase 3 study consists of two cohorts:
- Cohort 1 (Extension): Includes participants previously enrolled under the original protocol who received NT-501 (M-CHFM) and will continue follow-up. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason.
- Cohort 2 (Expansion): Includes newly enrolled participants randomized 1:1 to receive either NT-501 (M-CHFM) or NT-501 (CHFM). Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Patricia Davis
- Telefonní číslo: 401-333-3880
- E-mail: p.davis@neurotechusa.com
Studijní místa
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East Melbourne, Austrálie
- Zatím nenabíráme
- Cerulea
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Kontakt:
- Thuy Chau
- E-mail: tchau@ceruleaclinicaltrials.org.au
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Vrchní vyšetřovatel:
- Penelope Allen, MD
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Perth, Austrálie
- Nábor
- Lion's Eye Institute
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Kontakt:
- Diana Bowman
- E-mail: diana.bowman@lei.org.au
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Vrchní vyšetřovatel:
- Ian Constable, MD
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Sydney, Austrálie
- Zatím nenabíráme
- Sydney Eye Hospital
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Kontakt:
- Emily Luu
- E-mail: emily.luu@sydney.edu.au
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Vrchní vyšetřovatel:
- Elisa Cornish, MD
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-
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California
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Walnut Creek, California, Spojené státy, 94598
- Aktivní, ne nábor
- Bay Area Retina Associates, A Medical Group
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Michigan
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Grand Rapids, Michigan, Spojené státy, 49546
- Aktivní, ne nábor
- Foundation for Vision Research
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Texas
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Bellaire, Texas, Spojené státy, 77401
- Aktivní, ne nábor
- Retina Consultants of Texas
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria
To participate in this study, the potential subject and at least 1 of their eyes must meet all of the following criteria:
- Subjects must have a positive diagnosis of MacTel with evidence of fluorescein leakage typical of MacTel and at least one of the other features that include hyperpigmentation that is outside of a 500-micron radius from the center of the fovea, retinal opacification, crystalline deposits, right-angle vessels, or inner/outer lamellar cavities seen clinically or on SD-OCT.
- Subject must have a break in the ellipsoid zone (EZ) (area of IS/OS loss) as measured by SD-OCT between 0.16 and 2.00 millimeters squared.
- Subject's best-corrected visual acuity (BCVA) is 54-letter score or better (20/80 or better) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at screening.
- Subject must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality retinal imaging.
- Subject must be greater than or equal to 21 years of age and less than 80 years of age at screening.
- Subject or their legally authorized representative must be able to provide written informed consent to participate in the study, in accordance with the International Conference on Harmonisation Good Clinical Practices guidelines, and local regulations, before initiating any study-related procedures.
Exclusion Criteria
To participate in this study, the potential subject must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):
- Subject is medically unable to comply with study procedures or follow-up visits.
- Subject received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months.
- Subject has ever received intravitreal anti-vascular endothelial growth factor (VEGF) therapy in the study eye OR has, within the past 3 months, received intravitreal anti-VEGF therapy in the fellow eye at randomization.
- Subject has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures, or outcome of the study (e.g., uncontrolled glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis).
- Subject has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted). The exceptions to this exclusion criteria include artificial tears or one glaucoma medication for early or intermediate primary open-angle glaucoma.
- Subject has evidence of intraretinal neovascularization or subretinal neovascularization (SRNV), as evidenced by hemorrhage, hard exudate, subretinal fluid or intraretinal fluid in either eye.
- Subject has evidence of intraretinal hyperreflectivity by OCT.
- Subject has evidence of central serous chorio-retinopathy in either eye.
- Subject has evidence of pathologic myopia in either eye.
- Subject has significant corneal or media opacities in either eye.
- Subject has had a vitrectomy, penetrating keratoplasty, trabeculectomy, or trabeculoplasty.
- Subject has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the Age -Related Eye Disease Study (AREDS) clinical lens grading system.
- Subject has undergone lens removal in the previous 3 months or YAG laser within 4 weeks.
- Previous participation in any Neurotech MacTel clinical trial unless the participant: (1) previously consented and screened for a MacTel study but was a screen failure solely due to insufficient lesion size; or (2) has completed participation in the prior Neurotech MacTel study, is not actively enrolled in another Neurotech MacTel study, and has an eligible study eye that was not the study eye in the previous trial.
- Subject was a participant in any other ocular related or ocular impacted clinical trial of an intervention (drug or device) within the last 6 months.
- Subject is on chemotherapy.
- Subject is pregnant or breastfeeding.
- Subject has a history of malignancy that would compromise the 12-month study survival.
- Subject with a history of ocular herpes virus in either eye.
- Subject has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations, and outcome assessments.
- Subject has evidence of subfoveal RPE hyperplasia.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Cohort 1 (Extension) - M-CHFM
Previously enrolled Cohort 1 participants received M-CHFM and will undergo evaluations of safety and efficacy from pre-surgery through month 24 or in the event of NT-501 explantation for any reason. |
Single implantation of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM) |
|
Experimentální: Cohort 2 (Expansion) - M-CHFM
Participants are randomized 1:1 to receive M-CHFM. Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason. |
Single implantation of NT-501 manufactured using the Medica - Clinical Hollow Fiber Membrane (M-CHFM) |
|
Aktivní komparátor: Cohort 2 (Expansion) - CHFM
Participants are randomized 1:1 to receive CHFM (US commercially available ENCELTO). Participants will undergo evaluations of safety and efficacy from pre-surgery through month 12 or in the event of NT-501 explantation for any reason. |
Single implantation of NT-501 manufactured using the Clinical Hollow Fiber Membrane (CHFM)
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cohort 1 (Extension) - Efficacy
Časové okno: Baseline to 24 months
|
Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye of NT-501 in participants who received NT-501 with M-CHFM |
Baseline to 24 months
|
|
Cohort 2 (Expansion) - Efficacy
Časové okno: Baseline to 12 months
|
Rate of change in EZ area loss as measured by en face imaging by Spectral-Domain Optical Coherence Tomography (SD-OCT) in the study eye of NT-501 in participants who received NT-501 with M-CHFM as compared to NT-501 with CHFM |
Baseline to 12 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cohort 1 (Extension) - Safety
Časové okno: Baseline to 24 months
|
Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) |
Baseline to 24 months
|
|
Cohort 2 (Expansion) - Safety
Časové okno: Baseline to 12 months
|
Incidence of ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) |
Baseline to 12 months
|
|
Cohort 1 (Extension) - Best Corrected Visual Acuity
Časové okno: Baseline to 24 months
|
Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart |
Baseline to 24 months
|
|
Cohort 2 (Expansion) - Best Corrected Visual Acuity
Časové okno: Baseline to 12 months
|
Percentage of participants with a loss of 15 letters or more in best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) distance chart |
Baseline to 12 months
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Cohort 1 (Extension) - Aqueous CNTF
Časové okno: Month 12 - Month 24
|
Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration |
Month 12 - Month 24
|
|
Cohort 2 (Expansion) - Aqueous CNTF
Časové okno: Baseline to 12 months
|
Either a binary result (present/absent) for measurable CNTF or actual CNTF concentration |
Baseline to 12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Thomas Aaberg, Jr., MD, Neurotech Pharmaceuticals
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
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Termíny zápisu do studia
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První zveřejněno (Aktuální)
Aktualizace studijních záznamů
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
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