Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
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|ClinicalTrials.gov Identifier: NCT01810042|
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : April 7, 2014
Last Update Posted : May 4, 2016
|Condition or disease||Intervention/treatment||Phase|
|Exudative Age-related Macular Degeneration||Drug: ranibizumab||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Other Name: intravitreal injection of ranibizumab (Lucentis, Novartis)
- Caliber of Choroidal New Vessel (CNV) [ Time Frame: 6 months ]Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.
- Lesion Size of CNV [ Time Frame: 6 months ]Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.
- Visual Acuity in ETDRS Letters [ Time Frame: 6 months ]Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.
- Visual Acuity Changes [ Time Frame: baseline and 6 months ]
Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline.
Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810042
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of, 602-739|
|Haeundae Baik Hospital|
|Busan, Korea, Republic of, 612-896|
|Principal Investigator:||Ji Eun Lee, MH, PhD||Pusan National Universtiy Hospital|