Abstract
Purpose: :
To assess efficacy of ranibizumab treatment in a homogenous group of patients: complement factor H Y402H-positive subjects with occult CNV subsequent to AMD. To compare results in homo- and heterozygotic patient groups.
Methods: :
30 CFH Y402H-positive patients - 18 women, 12 men, mean age 70.5 (55-79), with occult CNV subsequent to AMD and confirmed with fluorescein angiography and OCT (Stratus III, Zeiss and Copernicus, Optopol). Y402H CFH variant was confirmed by PCR followed by gene sequencing. There was 12-month observation period. Every month patients were assessed by means of both time-domain and spectral OCT to determine necessity of retreatment. Time-domain OCT was used to obtain morphometric data while spectral OCT was performed to assess morphology of the retina. After first 3 monthly injections patients were retreated on the basis of best corrected visual acuity (BCVA by ETDRS) and foveal thickness. Retreatment criteria: loss of more than 5 letters on an ETDRS chart (compared with the highest value of BCVA at first 3 visits) and intraretinal cysts/subretinal fluid present or more than 100 µm increase in foveal thickness (compared with the lowest value at first 3 visits) even with no visual acuity worsening. Statistical analysis including t-test was performed to evaluate data significance (p<0.05).
Results: :
19 patients were heterozygotic, 11 patients were homozygotic. Mean number of injections per patient was 5.69±1.25. Mean BCVA (all patients) at baseline/1 month after first injection/at close-up was respectively: 54.30±8.44/59.38±9.0/57.0±8.53 letters, in homozygotic group: 58.17±8.13/62.83±11.49/58.67±11.30 letters, in heterozygotic group: 51.0±7.56/56.42±6.64/55.57±6.27 letters. Mean foveal thickness (all patients) at baseline/1 month after first injection/at close-up was respectively: 314.15±51.1/259.46±69.32/231.77±56.71 µm, in homozygotic group: 300.33±34.87/262.17±50.45/231.67±42.66 µm, in heterozygotic group: 308.28±63.0/247.71±64,89/224.57±53.22 µm. The difference between homo-/heterozygotic groups was not statistically significant.
Conclusions: :
Although we noticed slight difference in efficacy between homo- and heterozygotic patients, it was not statistically significant. Further investigation on larger population is needed. Injections of ranibizumab are an efficient way to maintain/increase visual acuity in CFH Y402H-positive patients with occult CNV subsequent to AMD.
Keywords: age-related macular degeneration • genetics • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials