The Laser intervention in early stages of age-related macular degeneration (LEAD) study (1) is a 36-month, multicenter, randomized, sham-controlled trial conducted from 2012-2015 of 292 participants with bilateral soft drusen, aka intermediate AMD (iAMD), who underwent q 6-month treatment with sub-threshold nanosecond laser (SNL) or sham treatment to the study eye. The primary efficacy outcome was the time to develop late AMD [geographic atrophy (GA) or choroidal neovascularization (CNV)] defined by multimodal imaging (MMI), which comprised spectral domain optical coherence tomography (SD-OCT), autofluorescence imaging (AF) and near-infrared reflectance imaging (NIR-R). Although progression to late AMD was not significantly slowed with SNL compared to sham for the entire group, posthoc analysis showed a significant benefit to those subjects without reticular pseudodrusen (RPD), and a worse outcome for those subjects with RPD, aka subretinal drusenoid deposits (SDD). SNL treatment may thus have a role in slowing progression for subjects without coexistent RPD/SDD and may be inappropriate in those with RPD/SDD. Further study is clearly warranted.
Keyphrases
- age related macular degeneration
- optical coherence tomography
- double blind
- high resolution
- randomized controlled trial
- clinical trial
- diabetic retinopathy
- computed tomography
- combination therapy
- mass spectrometry
- magnetic resonance imaging
- photodynamic therapy
- drug delivery
- study protocol
- placebo controlled
- cross sectional
- case report