Informations générales (source: ClinicalTrials.gov)
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)
Interventional
Phase 3
AbbVie (Voir sur ClinicalTrials)
décembre 2021
novembre 2026
17 octobre 2024
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy
for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet
AMD is characterized by loss of vision due to new, leaky blood vessel formation in the
retina. Wet AMD is a significant cause of vision loss in the United States, Europe and
Japan, with up to 2 million people living with wet AMD in these geographies alone.
Current anti-vascular endothelial growth factor (VEGF) therapies have significantly
changed the landscape for treatment of wet AMD, becoming the standard of care due to
their ability to prevent progression of vision loss in the majority of patients. These
therapies, however, require life-long intraocular injections, typically repeated every
four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment,
patients often experience a decline in vision with reduced frequency of treatment over
time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
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 Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | Contact (sur clinicalTrials) | ||||
| CHI DE CRETEIL | 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 | |||||
| CHU Nantes - Hopital Hotel Dieu Nantes - 44093 - Nantes - Loire-Atlantique - France | Contact (sur clinicalTrials) | ||||
| Clinique Honoré Cave - 82000 - Montauban - Midi-Pyrenees - France | Contact (sur clinicalTrials) | ||||
| Hopital de la Crois Rousse - 69004 - Lyon - Rhone - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Age ≥ 50 years and ≤ 89 years
2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the
study eye previously treated with anti-VEGF
4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
5. Willing and able to provide written, signed informed consent for this study
6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at
study entry
1. Age ≥ 50 years and ≤ 89 years
2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the
study eye previously treated with anti-VEGF
4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
5. Willing and able to provide written, signed informed consent for this study
6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at
study entry
1. CNV or macular edema in the study eye secondary to any causes other than AMD
2. Subfoveal fibrosis or atrophy in the study eye
3. Any condition in the investigator's opinion that could limit VA improvement in the
study eye
4. Active or history of retinal detachment, or current retinal tear that cannot be
treated, in the study eye
5. Advanced glaucoma or history of secondary glaucoma in the study eye
6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within
the past 6 months.
7. History of intraocular surgery in the study eye within 12 weeks prior to
randomization
8. History of intravitreal therapy in the study eye, such as intravitreal steroid
injection or investigational product, other than anti-VEGF therapy, in the 6 months
prior to Screening Visit 1.
9. Prior treatment with gene therapy.