Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Australia ; and.
Ophthalmology, Department of Surgery, The University of Melbourne, Melbourne, Australia.
Retina. 2024 Jul 1;44(7):1224-1231. doi: 10.1097/IAE.0000000000004080.
There is a need for robust earlier biomarkers of atrophic age-related macular degeneration that could act as surrogate endpoints for geographic atrophy (GA) in early interventional trials. This study sought to examine the risk of progression of complete retinal pigment epithelium and outer retinal atrophy (cRORA) to the traditional atrophic endpoint of GA on color fundus photography. This study also compared the risk of progression for cRORA to that associated with the specific optical coherence tomography features that define nascent GA (nGA), a strong predictor of GA development.
One hundred forty participants with bilateral large drusen at baseline underwent optical coherence tomography imaging and color fundus photography at 6-month intervals for up to 36 months. Optical coherence tomography volume scans were graded for the presence of cRORA and nGA, and color fundus photographs were graded for the presence of GA. The association and rate of progression to GA for cRORA and nGA were examined.
Both cRORA and nGA were significantly associated with GA development (adjusted hazard ratio, 65.7 and 76.8 respectively; both P < 0.001). The probability of progression of cRORA to GA over 24 months (26%) was significantly lower than the probability of progression of nGA (38%; P = 0.039).
This study confirmed that cRORA was a significant risk factor for developing GA, although its rate of progression was slightly lower compared with nGA. While requiring replication in future studies, these findings suggest that the specific features of photoreceptor degeneration used to define nGA appear important when assessing the risk of progression.
需要有稳健的萎缩性年龄相关性黄斑变性早期生物标志物，以便在早期干预试验中充当地理萎缩（GA）的替代终点。本研究旨在检查完全视网膜色素上皮和外层视网膜萎缩（cRORA）进展为传统 GA 萎缩终点的风险。本研究还比较了 cRORA 进展的风险与定义新生 GA（nGA）的特定光学相干断层扫描特征的进展风险，nGA 是 GA 发展的强有力预测因子。
140 名参与者在基线时有双侧大玻璃膜疣，在 36 个月的时间内每 6 个月接受一次光学相干断层扫描成像和眼底彩色照相检查。对 cRORA 和 nGA 的存在进行光学相干断层扫描体积扫描分级，并对 GA 的存在进行眼底彩色照相分级。检查了 cRORA 和 nGA 与 GA 进展的相关性和进展速度。
cRORA 和 nGA 均与 GA 发展显著相关（调整后的危险比分别为 65.7 和 76.8；均 P < 0.001）。cRORA 进展为 GA 的 24 个月的概率（26%）明显低于 nGA 的概率（38%；P = 0.039）。
本研究证实 cRORA 是 GA 发展的一个重要危险因素，尽管其进展速度略低于 nGA。虽然需要在未来的研究中进行复制，但这些发现表明，用于定义 nGA 的光感受器变性的特定特征在评估进展风险时很重要。
