This protocol applies to patients with diabetic retinopathy who have progressed to severe nonproliferative diabetic retinopathy (NPDR) or non-high-risk proliferative diabetic retinopathy (PDR).
Severe NPDR is diagnosed when defined disease signs progress beyond specific thresholds. Severe NPDR and non-high-risk PDR are addressed together because clinical trial data demonstrated they follow a similar course, and treatment recommendations for both stages are closely aligned.
The primary objective is a two-step or greater improvement in Diabetic Retinopathy Severity Scale (DRSS) level, reducing the risk of vision loss as retinopathy advances toward high-risk characteristics.
Patients at this stage are candidates for intervention aimed at reducing the risk of vision loss. The approach involves either a form of retinal laser surgery or an intravitreal injection therapy — the choice and timing depend on clinical factors including the presence of macular oedema and whether high-risk characteristics have yet developed.
The full regimen — including the specific interventions, sequencing criteria, and the evidence informing when treatment may be deferred or applied early — is available via the structured protocol below.
When these signs progress beyond certain defined thresholds, severe NPDR is diagnosed (see Table 1).
Severe NPDR and non-high-risk PDR are discussed together because ETDRS data showed that they have a similar clinical course and subsequent recommendations for treatment are similar.
Such patients should be considered candidates for treatment with PRP or anti-VEGF agents (see Care Process).
The ETDRS demonstrated that although PRP may be postponed until high-risk characteristics develop in eyes with DME, early PRP treatment could be considered, particularly for eyes with very severe NPDR and non-high-risk PDR.
The ETDRS protocol for full PRP included 1200 to 1600 spots of moderate burns of 0.1 second duration that is a one-half burn width apart and at least 2 disc diameters from the fovea out to the equator.
Greater proportions of aflibercept-treated eyes showed a two-step or greater improvement in DRSS level at 24, 52, and 100 weeks.
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