A Phase I Randomized Trial of Topical Insulin for Glaucoma: Safety and Efficacy Outcomes
Bibliographic record
Abstract
PURPOSE Insulin is neuroprotective in mouse and non-human primate models of glaucoma. Here we evaluate the safety and efficacy of topical insulin in human patients with glaucoma. METHODS This prospective study of once-daily topical insulin for glaucoma was conducted in two parts: an open-label dose escalation phase evaluating low (100 units/mL) and high doses (500 units/mL), followed by a randomized, masked trial comparing low and high dose topical insulin. The worse-affected eye served as the study eye while the contralateral eye served as a control. The primary endpoint was safety and tolerability, monitored by recording adverse events (AEs), intraocular pressure (IOP), and serum blood glucose and potassium levels. Secondary endpoints included structural and functional testing including visual acuity (VA), 24-2 Humphrey visual field (HVF), optical coherence tomography (OCT), and macular and peripapillary flavoprotein fluorescence (FPF). RESULTS Safety and tolerability were favorable for topical insulin at both doses, with no serious AEs. The most frequent AE was transient stinging, resolving almost immediately following application to the study eyes. Blood glucose levels remained consistently stable before and after insulin administration for all groups. In Group 3, five out of 15 study eyes showed an increase of average retinal nerve fiber layer (RNFL) thickness by 5 μm or more, compared to 0 of 12 fellow eyes from baseline to the 1-month visit (p=0.0476). On average, study eyes showed a larger increase in RNFL thickness compared to fellow eyes (1.11 μm in fellow eyes vs. 2.50 μm in study eyes) with no evidence of cystoid edema, and no difference detected between the two dose levels. The RNFL increase reversed to baseline by 1 month following cessation of insulin treatment. There were no changes in HVF or FPF during a 4-week administration period. CONCLUSIONS The application of topical insulin proved safe and well-tolerated among patients with glaucoma. Notably, one month of topical insulin led to a significant, reversible increase in RNFL thickness, indicating evidence for pharmacodynamic effect at the retina after topical delivery. These data support study initiation to evaluate topical insulin's neuroprotective or neuroenhancement effects.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".