Trial reportJournal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society2019
Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy.
Trial report in Journal of neuro-ophthalmology : the official journal of the North American Neuro-Ophthalmology Society, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION
Who cites it
11 citing papers in PubMed.
- A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers.Clinical pharmacology in drug development · 2020Trial
- Pathogenesis of Non-Arteritic Anterior Ischemic Optic Neuropathy Associated with COVID-19.International journal of molecular sciences · 2026Review
- Ischemic Optic Neuropathy: A Review of Current and Potential Future Pharmacotherapies.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Review of evidence for treatments of acute non arteritic anterior ischemic optic neuropathy.Eye (London, England) · 2024Review
- Non-Arteritic Anterior Ischemic Optic Neuropathy (NA-AION): A Comprehensive Overview.Vision (Basel, Switzerland) · 2023Review
- Extracellular-Vesicle-Based Therapeutics in Neuro-Ophthalmic Disorders.International journal of molecular sciences · 2023Review
- Non-arteritic anterior ischaemic optic neuropathy (NA-AION) and COVID-19 vaccination.BMJ case reports · 2022Article
- Review
- Neuroprotective Strategies for Retinal Ganglion Cell Degeneration: Current Status and Challenges Ahead.International journal of molecular sciences · 2020Review
- Delayed (21 Days) Post Stroke Treatment With RPh201, a Botany-Derived Compound, Improves Neurological Functional Recovery in a Rat Model of Embolic Stroke.Frontiers in neuroscience · 2020Article
- Therapeutic effects of herbal medicines in different types of retinopathies: A systematic review.Avicenna journal of phytomedicineReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
backgroundNo proven treatment exists for nonarteritic anterior ischemic optic neuropathy (NAION), either in the acute or late phase.
objectiveTo assess safety and changes in visual function and structure after RPh201/placebo treatment in participants with previous NAION. DESIGN AND
settingPhase 2a, single-site, prospective, randomized, placebo-controlled, double-masked trial (registration NCT02045212). MAIN OUTCOMES MEASURES: Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA), visual fields, retinal nerve fiber layer, and visual evoked potential at weeks 13, 26, and after a 13-week wash-out ("off-drug") period; and safety. STUDY POPULATION: Twenty-two participants aged 18 years or older with previous NAION. INTERVENTION(S): RPh201 (20 mg) or placebo (cottonseed oil vehicle) administered subcutaneously twice weekly at the study site.
resultsThirteen men and 9 women were randomized, of which 20 completed all visits. The mean (±SD) age was 61.0 ± 7.6 years. In a post hoc analysis, after 26 weeks of treatment, BCVA improved by ≥15 letters in 4/11 (36.4%) eyes with RPh201, compared to 1/8 (12.5%) eyes with placebo (P = 0.24). Overall, 7/11 (63.6%) of participants on RPh201 showed some improvement in BCVA, compared with 3/8 (37.5%) on placebo (P = 0.26). Improvement in BCVA from a calculated baseline was 14.8 ± 15.8 letters for RPh201 and 6.6 ± 15.3 for placebo (P = 0.27). Of the 154 adverse effects (AEs), 52 were considered related to the study procedures/treatment. Across the study and 1,017 injections, the most frequently reported AE was injection site pain (23 events in 5 participants). There were no clinically significant changes in vital signs or laboratory values.
conclusionsThis Phase 2a was designed to assess safety, feasibility, and explore potential efficacy signals in treating previous NAION with RPh201. No safety concerns were raised. The results support a larger trial in patients with previous NAION.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.