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Purpose To compare evaluation by clinical examination with image grading at a reading center (RC) for the classification of diabetic retinopathy (DR) and diabetic macular edema (DME). Methods ACCORD and FIND had similar methods of clinical and fundus photograph evaluation. For analysis purposes the photographic grading scales were condensed to correspond to the clinical scales and agreement between clinicians and reading center classification were compared. Results 6902 eyes of ACCORD participants and 3638 eyes of FIND participants were analyzed for agreement (percent, kappa) on DR on a 5 level scale. Exact agreement between clinicians and RC on DR severity category was 69% in ACCORD and 74% in FIND (Kappa 0.42 and 0.65). Sensitivity of the clinical grading to identify presence of mild nonproliferative retinopathy or worse was 0.53 in ACCORD and 0.84 in FIND. Specificities were 0.97 and 0.96, respectively. DME agreement in 6649 eyes of ACCORD participants and 3366 eyes of FIND participants was similar in both studies (Kappa 0.35 and 0.41). Sensitivities of the clinical grading to identify DME were 0.44 and 0.53 and specificities were 0.99 and 0.94, respectively. Conclusion Our results support the use of clinical information for defining broad severity categories, but not for documenting small to moderate changes in DR over time.