Clinical trial

OCTA-Directed PDT Triple Therapy for Treatment-Naïve Patients With Exudative Age-Related Macular Degeneration Versus Standard of Care Anti-VEGF(Anti-vascular Endothelial Growth Factor) Monotherapy

Name
IRB00058375
Description
Optical Coherent Tomography Angiography (OCTA)-Directed PDT Triple Therapy for Treatment-Naïve Patients with Exudative Age-related Macular Degeneration (ARMD) versus Standard of Care Anti-VEGF Monotherapy
Trial arms
Trial start
2023-03-30
Estimated PCD
2024-11-01
Trial end
2024-12-01
Status
Withdrawn
Phase
Early phase I
Treatment
Ranibizumab
Intravitreal injection 0.5 MG Per 0.05 ML Injection.
Arms:
Arm A: Lucentis, Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense
Other names:
Lucentis
Photodynamic laser treatment (PDT)
PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds.
Arms:
Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense
Triamcinolone Acetonide
Intravitreal injection of 0.5ml-2mg
Arms:
Arm C: Lucentis, PDT Laser and Triescense
Other names:
Triesence
verteporfin
Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
Arms:
Arm B: Lucentis & PDT Laser, Arm C: Lucentis, PDT Laser and Triescense
Other names:
Visudyne
Primary endpoint
Percentage of subretinal exudation resolution
6 months
Percentage of intraretinal exudation resolution
6 months
Eligibility criteria
Inclusion Criteria: * Willing to give written informed consent * Willing and able to comply with all study procedures for the duration of the study. * Presence of Exudative ARMD with evidence of choroidal neovascularization: type 1, 2, and/or 3 on spectral domain OCT, fluorescein angiography, indocyanine green angiogram and optical coherent tomography angiography * Visual Acuity of 20/25 to 20/400 at screening and baseline visits using an autorefractor or Early Treatment Diabetic Retinopathy Study * Intraocular pressure less than or equal to 25mmHG * Females of childbearing potential that are willing to use medically acceptable methods of birth control. Exclusion Criteria: * Exudation maculopathies without drusen * Previous treatment with macular photocoagulation, anti-VEGF medication or PDT with Visudyne * Myocardial infarction or cerebrovascular accident within the last 6 weeks * Previous vitrectomy * Optic neuropathy * Diabetic retinopathy * Traction maculopathies * Allergies to fluorescein and indocyanine, dilating agents or anti-VEGF medications * Have received previous treatment for ARMD * Any uncontrolled condition or illness that in the opinion of the investigator makes the subject unsuitable for the study
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}
Updated at
2024-03-22

1 organization

3 products

1 indication