- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00967213
Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration
April 21, 2016 updated by: Novartis Korea Ltd.
Changes in Preferential Hyperacuity Perimeter (PHP) and Fundus Autofluorescence (FAF) in Patients With Neovascular Age-related Macular Degeneration Receiving Combination of Ranibizumab and Verteporfin Therapy
The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®) therapy
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 130-702
- Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed written informed consent
- Age ≥ 50 years old
- Patients with primary active subfoveal CNV secondary to AMD
- Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart
Characteristics of AMD lesion
- predominantly or minimally classic, or occult
- absence of prior subfoveal treatment for macular disease
- total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case < 50% CNV was acceptable)
- active choroidal neovascularization leakage
- submacular blood < 50% and subretinal fibrosis < 25% of the total lesion
Exclusion Criteria:
- additional eye disease that could compromise VA
- CNV unrelated to AMD
- ocular inflammation
- vitreous hemorrhage
- retinal hemorrhage (other than AMD related submacular blood) > 1 disc areas
- intraocular surgery ≤ 1 month before day 0
- uncontrolled glaucoma
- prior treatments with verteporfin PDT
- laser photocoagulation or other intervention for AMD
- previous treatment with external-beam radiation therapy or transpupillary thermotherapy
- history of vitrectomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Ranibizumab
three session of monthly injection of Lucentis® (week 0, 4, 8).
After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks.
Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
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Lucentis® (ranibizumab) 0.3mg (0.05ml volume) intravitreal injection.
Eligible patients will be initially received three session of monthly injection of Lucentis® (week 0, 4, 8).
After 4 weeks from third injection, a session of verteporfin PDT (week 12) and fourth injection of Lucentis® (week 16) will be added at intervals of 4 weeks.
Two more combined treatment with verteporfin PDT and Lucentis® injection 4 weeks apart can be added at the treating physician's discretion in 3-month intervals (week 28, week 40).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The change in ETDRS visual acuity letter scores from baseline.
Time Frame: every 4 weeks (up to 52 weeks)
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every 4 weeks (up to 52 weeks)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect on CNV and RPE using preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF). Retinal thickness using optical coherence tomography (OCT). Recurrence of fluorescein leakage. The need for additional PDT treatment
Time Frame: every 4 weeks (up to 52 weeks)
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every 4 weeks (up to 52 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Hyung-Woo Kwak, Dept. of ophthalmology, KyungHee Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (ACTUAL)
February 1, 2008
Study Registration Dates
First Submitted
August 26, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (ESTIMATE)
August 27, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
April 22, 2016
Last Update Submitted That Met QC Criteria
April 21, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CBPD952AKR03
- CCT-NAPN-18335
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.
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