Testing the eligibility of glaucoma patients for potential gene therapy among a clinic population.

ABSTRACT

PURPOSE: Glaucoma patients who deteriorate despite standard treatment may benefit from novel gene therapies. Key inclusion criteria for a glaucoma gene therapy trial were devised. A retrospective chart review in a glaucoma clinic population was conducted. Feasibility of gene therapy inclusion criteria and factors associated with progression and fast progression < -1 decibels/year (dB/y) were evaluated. METHODS: Three hundred and seventy-four primary open-angle glaucoma patients all of whom had performed at least five Swedish interactive threshold algorithm standard visual fields within a 58-month period. Two definitions were applied to characterize visual field progression rate using Guided Progression Analysis for an individual patient based on A, the eye with the greatest visual field loss, or B, the eye with the most rapid progression rate. RESULTS: Mean rate of visual field progression was -0.50 dB/y (Definition A) and -0.64 dB/y (Definition B). 19.0% (A) and 21.9% (B) of eyes, 71 (A) and 82 (B) eyes, were 'fast progressors' (< -1 dB/y). 37 (A) and 43 (B) eyes met the putative gene therapy inclusion criteria (≥ 50 years; mean deviation ≤ -4 to ≥ -12 or ≤ -20 dB, progression rate between -1 and -4 dB/y). Beta blockers (Odds ratio (OR) with 95% Confidence Intervals (CI) 2.84 (1.39-5.80); p = 0.004) (A), (OR (95%CI) 2.48 (1.30-4.75); p = 0.006) (B) and alpha agonists (OR (95%CI) 2.18 (1.14-4.17); p = 0.02) (A), (OR (95%CI) 2.00 (1.08-3.73); p = 0.028) (B) were significantly associated with fast progression. CONCLUSION: A substantial proportion (10%) of patients in this clinic population would meet recommended gene therapy inclusion criteria.