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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.
For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ranibizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ranibizumab | Drug | 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Caliber of Choroidal New Vessel (CNV) | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lesion Size of CNV | Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels. | 6 months |
| Visual Acuity in ETDRS Letters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Eun Lee, MH, PhD | Pusan National Universtiy Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Busan | 602-739 | South Korea | |||
| Haeundae Baik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15177969 | Background | Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. doi: 10.1016/j.ophtha.2003.09.039. | |
| 17021318 | Background |
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This study has a single arm, and there was no assignment process.
Total 53 patients were screened and 49 patients were enrolled from Oct 2010 to Feb 2013 in Pusan National University Hospital and Inje Baik Haeundae Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Of 39 patients completed the study, 8 patients were excluded because 6 patients had polypoidal choroidal vasculopathy, and 2 patients had poor quality of indocyanine green angiography.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Caliber of Choroidal New Vessel (CNV) | 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. | Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement. | Posted | Mean | Full Range | micrometer | 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ranibizumab | Ranibizumab is injected monthly 3 times then PRN to 6 months. intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebral infarction | Nervous system disorders | Systematic Assessment | As the symptom was mild and onset after more than 2 months from the last injection, the serious adverse event (SAE) was categorized as 'Probably not' and reported to the Institutional Review Board (IRB). |
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Small number of cases, high rate of follow-up loss. Technical problem with measuring caliber of choroidal new vessels.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ji Eun Lee | Pusan National University Hospital | +82-51-240-7957 | jlee@pusan.ac.kr |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C014635 | lactitol |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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.
| 6 months |
| Visual Acuity Changes | 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. | baseline and 6 months |
| Busan |
| 612-896 |
| South Korea |
| Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481. |
| 17021319 | Background | Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655. |
| 16386991 | Background | Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. doi: 10.1016/j.ajo.2005.07.025. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Median visual acuity (ETDRS) | Visual acuity was measured using a Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. The ETDRS score represents the number of letters that the patient read correctly. It can be ranged from 0 to 85. An ETDRS score of 85 corresponds to 20/20 vision approximately, and a score of 35 corresponds to 20/200 vision. | Median | Full Range | ETDRS letter |
|
| Central subfield macular thickness (um) | Median | Full Range | micrometer |
|
|
|
| Secondary | Lesion Size of CNV | Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels. | Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy. | Posted | Mean | Full Range | square milimeter | 6 months |
|
|
|
| Secondary | Visual Acuity in ETDRS Letters | 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. | Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy. | Posted | Median | Full Range | ETDRS letters | 6 months |
|
|
|
| Secondary | Visual Acuity Changes | 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. | Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy. | Posted | Median | Full Range | ETDRS letters | baseline and 6 months |
|
|
|
| 2 |
| 49 |
| 0 |
| 49 |
|
| Liver cirrhosis | Gastrointestinal disorders | Systematic Assessment | The patient had alcoholic hepatitis, and hospitalized due to worsening of alcoholic liver cirrhosis. |
|
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| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |