- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00802126
Intravitreal Bevacizumab and Low Fluence Photodynamic Therapy
Efficacy of Combining Intravitreal Bevacizumab With Photodynamic Therapy Using Reduced Light Fluence Rate in Choroidal Neovascularization Secondary to Pathologic Myopia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this retrospective interventional case series, 16 patients with myopic CNV were included. All patients were treated with 1.25 mg of intravitreal bevacizumab followed by RF-PDT (25 J/cm²), 2 days later. All patients were previously treated with IVB monotherapy and active leaking of CNV occurred 90 to 120 days after the treatment.
Best-corrected visual acuity (BCVA-ETDRS), foveal thickness (FT) on optical coherence tomography (OCT), and fluorescein and indocyanine green angiographic (FA; ICG) findings were recorded. Follow-up evaluations were carried out for 12 months.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Napoli, Italy, 80100
- Ophthalmology Department SUN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Myopic CNV, CNV leakage
Exclusion Criteria:
- CNV not associated with high myopia
- No activity of CNV
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bevacizumab and verteporfin
|
low-fluence photodynamic therapy combined with intravitreal bevacizumab
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BCVA improved
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
no CNV leakage
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Study Director: Michele Rinaldi, MD, PhD, University of Campania "Luigi Vanvitelli"
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81613
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myopia
-
He Eye HospitalNot yet recruiting
-
University of BradfordCoopervision, Inc.; University of HuddersfieldNot yet recruiting
-
Visioneering Technologies, IncRecruitingMyopiaUnited States, Canada, Hong Kong, Singapore
-
University Eye Hospital, FreiburgRecruiting
-
Shanghai 10th People's HospitalCompletedMyopia | Myopia, ProgressiveChina
-
Tianjin Eye HospitalActive, not recruiting
-
Tianjin Eye HospitalCompleted
-
Sultan Qaboos UniversityChristian Medical College, Vellore, IndiaUnknown
-
Peking University People's HospitalUnknownProgressive MyopiaChina
-
Shanghai Eye Disease Prevention and Treatment CenterNot yet recruiting
Clinical Trials on Combination therapy "IVB + rf-PDT"
-
Singapore National Eye CentreNational University Hospital, Singapore; Tan Tock Seng HospitalActive, not recruitingPolypoidal Choroidal VasculopathySingapore
-
Centre Hospitalier Universitaire de NiceWithdrawnDystrophic Epidermolysis BullosaFrance
-
Biofrontera Bioscience GmbHActive, not recruitingSuperficial Basal Cell CarcinomaUnited States
-
Biofrontera Bioscience GmbHRecruiting
-
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...Not yet recruitingPort-Wine Stain | Nevus Flammeus | Port-wine Birthmark
-
Theralase Inc.University Health Network, Toronto; WCCT Global; Medelis Inc.CompletedNon-Muscle Invasive Bladder Cancer (NMIBC) Refractory to BCGCanada
-
Sheffield Teaching Hospitals NHS Foundation TrustOndine Biomedical Inc.CompletedPeriodontitisUnited Kingdom
-
Oxford University Hospitals NHS TrustCompletedAtrial FibrillationUnited Kingdom
-
First People's Hospital of HangzhouCompleted
-
Linkoeping UniversitySwedish Council for Working Life and Social ResearchTerminatedMajor Depressive DisorderSweden