Effect of fluoxetine on adult amblyopia: a placebo-controlled study combining neuroplasticity-enhancing pharmacological intervention and perceptual training

Amblyopia is a common visual disorder that is treatable in childhood. However, therapies have limited efficacy in adult patients with amblyopia. Fluoxetine can reinstate early-life critical period-like neuronal plasticity and has been used to recover functional vision in adult rats with amblyopia. This phase 2, randomized, double-blind (fluoxetine vs. placebo), multicenter clinical trial examined whether or not fluoxetine can improve visual acuity in amblyopic adults. This interventional trial included 42 participants diagnosed with moderate to severe amblyopia. Subjects were randomized to receive either 20 mg fluoxetine (n=22) or placebo (n=20). During the 10-week treatment period, all subjects performed daily computerized perceptual training and eye patching. There was no significant difference in treatment efficacy between the groups. Visual acuity at the primary endpoint had significantly improved over baseline in both the fluoxetine (-0.167 logMAR) and placebo (-0.194 logMAR) groups (both p