Exudative Age-related Macular Degeneration
Conditions
Keywords
age-related macular degeneration, choroidal neovascularization, ranibizumab, indocyanine angiography
Brief summary
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.
Detailed description
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.
Interventions
DRUGranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Sponsors
Novartis
Pusan National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age \>= 50 2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better 3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area. 4. Area of CNV clearly visible in ICGA is more than half of the total CNV area.
Exclusion criteria
1. CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc) 2. Blocked fluorescence in ICGA is more than half of the total CNV area. 3. Disciform scar 4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months 5. Previous any treatment of photodynamic therapy or photocoagulation 6. Previous intraocular or periocular injection of steroid within 3 months 7. Previous intraocular surgery except cataract surgery 8. Vitreo-retinal interface disease on the macula 9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.) 10. Uncontrolled periocular or intraocular infection 11. History of hypersensitivity to ranibizumab treatment 12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caliber of Choroidal New Vessel (CNV) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Size of CNV | 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 | 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 | 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. |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
This study has a single arm, and there was no assignment process.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 10 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Continuous | 69 years |
| Central subfield macular thickness (um) | 317 micrometer |
| Median visual acuity (ETDRS) | 46 ETDRS letter |
| Region of Enrollment Korea, Republic of | 31 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 2 / 49 |
Outcome results
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.
Time frame: 6 months
Population: Of 31 patients included in the baseline analysis, 7 patients had the thickest vessels under limitation of measurement.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ranibizumab | Caliber of Choroidal New Vessel (CNV) | 43.53 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.
Time frame: 6 months
Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ranibizumab | Lesion Size of CNV | 3.03 square milimeter |
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.
Time frame: baseline and 6 months
Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ranibizumab | Visual Acuity Changes | 12.5 ETDRS letters |
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.
Time frame: 6 months
Population: Among 39 patients who completed the study, 8 patients were excluded because of poor ICGA quality or presence of polypoidal choroidal vasculopathy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ranibizumab | Visual Acuity in ETDRS Letters | 69 ETDRS letters |