A retrospective review was conducted of a cohort of sequential eyes with geographic atrophy threatening the fovea or with the fovea recently involved that were treated under a compassionate use off label compounded Procrit administered intravitreal, 5 IU every 6 weeks with complete ocular examinations performed at the 6 week intervals and SD OCT, IVFA, and OFAP every 3 months. SDOCT images were overlaid on the fluorescein angiograms and autofluorescence images and analyzed for loss of photoreceptor ellipsoid junction, loss of outer plexiform layer (OPL), and retinal pigment epithelium (RPE) redundancy or thickening. The primary outcome measure was rate of GA area progression during treatment compared with rates prior to treatment. Secondary outcomes were rate of GA progression in treated eyes compared GA progression when observed in the fellow eyes (without choroidal neovascularization), as well as the change in OMFAP Global Macular Acuity (GMA) during treatment compared with prior to treatment and compared with the fellow eye.
Results: 32 eyes of 28 patients were included were included, all of which had been followed for at least six months prior to and then at least one year during treatment. The treated eyes often were the second to be involved with the GA and therefore started with slightly smaller GA (averaging 7.63+/- 7.56 mm2) compared with the fellow eye (8.59+/- 8.28 mm2) but enlarged prior to treatment at a faster rate (130+/-164%) than that in the fellow eye (86+/-151%). During treatment the starting areas in the treated eyes were similar with that in the fellow eyes, but eh area enlargement was reduced by 72% compared with a slowing of only 33% in the fellow eyes during the same period (which is the expected slowing as the areas enlarge and coalesce with reduction in perimeter/area ratio. On OFAP testing the Global Macular Acuity during treatment improved on average 0.12 logMAR (+/- 0.21) while in the fellow eyes an average loss of 0.14 logMAR(+/-0.27) was recorded. Among the treated eyes, 23% improved 0.3 logMar or greater compared with none of the fellow eyes. None of the treated eyes lost 0.3logMAR compared with 22% of the fellow eyes.
On SDOCT disruption of the PEJ typically extended beyond the margins of geographic atrophy on IVFA or autofluorescence while RPE thickening often lined the margin. The best indicators of future GA progression were loss of OPL or loss of the PEJ. CVFAP scotomas corresponded with OCT loss of the OPL and PEJ.
Conclusions: In a small pilot study, intravitreal Procrit appears to slow GA progression and central vision loss. OCT and CVFAP appear to be useful for mapping preserved retina and vision, monitoring disease progression, and predicting GA expansion.