NCT06164587Befejeződött1/2. fázis
Evaluation of Kamuvudine-8 in Subjects With Geographic Atrophy
A Non-Randomized, Open Label, Safety and Efficacy Study Evaluating Kamuvudine-8 (K8) for the Treatment of Patients With Geographic Atrophy
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 20.
Rövid összefoglaló (regiszter, angolul)
This interventional study is a single-center, open label, 26-week study, designed to evaluate the safety and treatment efficacy of K8 in patients with geographic atrophy (GA) due to age-related macular degeneration (AMD). Up to 5 subjects will receive study medication. Study treatment will be administered by intravitreal injections. Number of participants has been expanded to 30. Participants will have 7 scheduled visits - Screening with baseline (injection), safety visit 2 days after injection, week 4, week 13 (injection), safety visit 2 days after injection, week 17, week 26. Exams will look for continuous changes in visual acuity, change in area of geographic atrophy lesions in diagnostic imaging, response measured by multifocal electroretinogram, change in reading speed, and change in microperimetry response.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 1/2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tényleges)
- Első benyújtás
- 2023. dec. 1.
- Kezdés
- 2024. ápr. 18.
- Elsődleges befejezés
- 2026. máj. 15.
- Fő szponzor
- Inflammasome Therapeutics
- Betegségek
- Időskori makuladegeneráció
- NCT-szám
- NCT06164587
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1/2. fázis
- Bevont résztvevők: 30
- 2024. ápr. 18. és az elsődleges befejezés (2026. máj. 15.) között
- 9 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Kiket keres a vizsgálat
- Aged 50 or older, diagnosed with geographic atrophy (GA) due to age-related macular degeneration (AMD).
- Best corrected visual acuity (BCVA) 24 or greater Early Treatment of Diabetic Retinopathy Study (ETDRS) letters (approximately Snellen 20/320 or greater), in study eye.
- The entire geographic atrophy (GA) lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy except in such cases where there is a "neck" or some narrow area connecting the GA with the peripapillary atrophy, as determined by Fundus Autofluorescence (FAF) imaging at screening:
- Both eyes must have GA and the total GA area in each eye must be ≥ 2.5 and ≤ 20.0 mm2 (1 and 8 disk areas [DA] respectively)
- If geographic atrophy (GA) is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above.
- If geographic atrophy (GA) is unifocal, then the lesion must be extrafoveal.
- Presence of any pattern of hyperautofluorescence in the junctional zone of geographic atrophy (GA). Absence of hyperautofluorescence (i.e., pattern = none) is exclusionary.
- Fundus Autofluorescence (FAF), spectral-domain optical coherence tomography (SD-OCT), or Fluorescein Angiography (FA) imaging of entire geographic atrophy (GA)lesion at least 6 months prior to entry.
- General Exclusion Criteria:
- Females who are pregnant, nursing, planning a pregnancy or who are of childbearing potential not using a reliable method of contraception
- History or current evidence of hypersensitivity to any components of the study medication or fluorescein, as assessed by the investigator
- Participation in any investigational drug or device study within 30 days prior to baseline
- History or current evidence of a medical condition or medication use that may, in the opinion of the investigator, preclude the safe administration of study medication or affect the results of the study
- Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary.
- Ocular Exclusion Criteria:
- Active ocular or periocular infections, malignancy
- History of major ophthalmic surgery in the past 3 months, and any ophthalmic surgery in study eye in the last 30 days
- History of significant ocular disease other than AMD that may confound results
- Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips or evidence of retinal, choroidal, or peripapillary neovascularization in either eye
- Known hypersensitivity to study drug or any of the excipients in implant
- Macular atrophy secondary to a condition other than AMD
- History of laser therapy in the macular region
- Aphakia or surgically compromised/absent posterior capsule including presence of scleral fixated lenses. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary
- History of prior posterior vitrectomy
- History of prior intraocular gene therapy for any indication
- History of extended hydroxychloroquine or pentosan polysulfate exposure (> 3 months)
- Current use of medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine [Plaquenil®], tamoxifen, phenothiazines, ethambutol, digoxin, pentosan polysulfate, and aminoglycosides).
- Uncontrolled glaucoma (defined as intraocular pressure >21mm Hg despite treatment with ocular hypotensive medications at baseline)
- Prior participation in another interventional clinical study or treatment for GA in the study eye including topical, IVT, subretinal, suprachoroidal, periocular or oral medication or placebo within 5 half-lives of the active ingredient
- Prohibited Medications/Treatments:
- Systemic anti-VEGF medications
- Intravitreal injections of Syfovre (pegcetacoplan), Izervay (avacincaptad pegol) or other complement inhibitors in either eye
- Gene therapy injections in either eye
Életkor a regiszterben: 50 év – 99 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (9)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Southeastern Retina Associates | Bristol | Egyesült Államok | Ismeretlen állapot |
| Oregon Eye Consultants, Cascade Medical Research | Eugene | Egyesült Államok | Ismeretlen állapot |
| Hilton Head Retina Institute | Hilton Head | Egyesült Államok | Ismeretlen állapot |
| Southeastern Retina Associates | Hixson | Egyesült Államok | Ismeretlen állapot |
| University of Kentucky Advanced Eye Care | Lexington | Egyesült Államok | Ismeretlen állapot |
| Loma Linda University | Loma Linda | Egyesült Államok | Ismeretlen állapot |
| The Maine Eye Center | Portland | Egyesült Államok | Ismeretlen állapot |
| Vistar Eye Center | Roanoke | Egyesült Államok | Ismeretlen állapot |
| Ophthalmology Ltd. | Sioux Falls | Egyesült Államok | Ismeretlen állapot |
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