Informations générales (source: ClinicalTrials.gov)
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia (POYANG)
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
mars 2024
novembre 2026
02 octobre 2024
This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled
study evaluating the efficacy and safety of faricimab in patients with myopic choroidal
neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus
0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial
active IVT treatment administration at randomization (Day 1).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | Contact (sur clinicalTrials) | ||||
| HOPITAL FONDATION A. DE ROTHSCHILD | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Ophtalmologique Maison-Rouge - 67000 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Centre Paradis Monticelli; Ophtalmologie - 13008 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Centres Ophtalmologique St Exupéry; Ophtalmologie - 37540 - St Cyr Sur Loire - France | Contact (sur clinicalTrials) | ||||
| CHNO des Quinze Vingts; Ophtalmologie - 75012 - Paris - France | Contact (sur clinicalTrials) | ||||
| CHU Nantes - Hôtel Dieu; Ophthalmology - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| Hopital de la croix rousse; Ophtalmologie - 69317 - Lyon cedex - France | Contact (sur clinicalTrials) | ||||
| Pole Vision Val d'Ouest; Ophtalmologie - 69130 - Ecully - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
2. Diagnosis of active myopic CNV in the study eye:
1. Presence of high myopia, worse than -6 diopters of spherical equivalence
2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
3. Presence of posterior changes compatible with pathologic myopia (e.g.,
tessellated fundus, lacquer cracks, etc.)
4. Presence of active leakage from CNV on FFA (determined by Central Reading
Centre [CRC])
5. Presence of intraretinal or subretinal fluid or increase of CST on OCT
(determined by CRC)
3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen
equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
on Day 1
4. Overtly healthy as determined by medical evaluation that includes medical history,
physical examination, and laboratory tests
5. Ability to comply with the study protocol, in the Investigator's judgment
6. Other protocol-defined inclusion criteria apply
1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
2. Diagnosis of active myopic CNV in the study eye:
1. Presence of high myopia, worse than -6 diopters of spherical equivalence
2. Antero-posterior elongation measurement greater than or equal to 26.0 mm
3. Presence of posterior changes compatible with pathologic myopia (e.g.,
tessellated fundus, lacquer cracks, etc.)
4. Presence of active leakage from CNV on FFA (determined by Central Reading
Centre [CRC])
5. Presence of intraretinal or subretinal fluid or increase of CST on OCT
(determined by CRC)
3. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen
equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
on Day 1
4. Overtly healthy as determined by medical evaluation that includes medical history,
physical examination, and laboratory tests
5. Ability to comply with the study protocol, in the Investigator's judgment
6. Other protocol-defined inclusion criteria apply
1. Any major illness or major surgical procedure within 1 month before screening
2. Pregnancy or breastfeeding, or intention to become pregnant during the study or
within 3 months after the final study treatment administration
3. Uncontrolled blood pressure (systolic >180 millimetres of mercury [mmHg], diastolic
>100 mmHg)
4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior
to Day 1
5. History of systemic or ocular disease that would contraindicate treatment with the
investigational drug or comparator
6. Uncontrolled glaucoma in study eye
7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities,
including, but not restricted to, intravitreal, periocular or laser interventions in
study eye
8. Prior or concomitant periocular or intravitreal pharmacological treatment, including
anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME
etc.) in study eye
9. Other protocol-defined exclusion criteria apply