Trial reportDrugs2020
24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients.
Trial report in Drugs, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01157364 (An Open-label), which is not on this map. Cited by 49 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.
An Open-label (Stage 1) and Randomized (Stage 2), 24 Month Study of Safety and Efficacy of Bimatoprost Drug Delivery System in Patients With Open-Angle Glaucoma or Ocular Hypertension
Who cites it
49 citing papers in PubMed, 99 citations in OpenAlex.
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- Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension.Clinical ophthalmology (Auckland, N.Z.) · 2023Trial
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- Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies.Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and TherapeuticsTrial
- Risk-Stratified Interventional Management and Surgical Decision-Making in Primary Glaucoma.Biomedicines · 2026Review
- Article
- Use of Bimatoprost Intracameral Implant for the Treatment of Glaucoma: A Focused Narrative Review.Cureus · 2026Review
- Prostaglandin analog therapy challenges and innovation in glaucoma therapeutics.Indian journal of ophthalmology · 2026Review
- Implants to Treat Glaucoma: Promising or Not?Drugs & aging · 2026Review
- Overview of Intracameral Drug Delivery Systems in Glaucoma.Clinical ophthalmology (Auckland, N.Z.) · 2026Review
- Impact of Antiglaucoma Drug Number and Class on Corneal Epithelial Thickness Measured by OCT.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Emerging trends in long-acting sustained drug delivery for glaucoma management.Drug delivery and translational research · 2025Review
- Unraveling the Mechanisms, Clinical Impact, Comparisons, and Safety Profiles of Slow-Release Therapies in Glaucoma.Pharmaceutics · 2025Review
- Interventional glaucoma: Rethinking glaucoma treatment paradigms in the Asian context.Indian journal of ophthalmology · 2025Review
- Frontier applications of retinal nanomedicine: progress, challenges and perspectives.Journal of nanobiotechnology · 2025Review
- Expert Opinion to Optimize Clinical Outcomes of Bimatoprost Intracameral Implant Treatment.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Retrospective Single-Center Outcomes After a First Bimatoprost Sustained-Release Implant.Clinical ophthalmology (Auckland, N.Z.) · 2025Article
- Challenging glaucoma with emerging therapies: an overview of advancements against the silent thief of sight.Frontiers in medicine · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG).
methodsThis was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs).
resultsAt month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes.
conclusionsBimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy. Clinicaltrials.gov identifier: NCT01157364.
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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.