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Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

NCT04075136 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-03-22

No results posted yet for this study

Summary

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

Conditions

  • Exudative Age Related Macular Degeneration

Interventions

DRUG

Ranibizumab

Intravitreal injection 0.5 MG Per 0.05 ML Injection.

DEVICE

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.

DRUG

Triamcinolone Acetonide

Intravitreal injection of 0.5ml-2mg

DRUG

verteporfin

Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.

Sponsors & Collaborators

  • Modulight

    collaborator UNKNOWN

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Mark Nelson, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2024-11-30
Completion
2024-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075136 on ClinicalTrials.gov