Evidence map›Paper›PMID 34495425›Full record

Trial reportJapanese journal of ophthalmology2021

Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study.

Makoto Aihara, Fenghe Lu, Hisashi Kawata, Akihiro Iwata, Noriko Odani-Kawabata

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Japanese journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02822729 (A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension), which is not on this map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
6.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

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.

2 · The registry

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.

NCT02822729 phase3completednot on this map

A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study

TypeinterventionalSponsorSanten Pharmaceutical Co., Ltd.Ran2016 to 2017Enrolled125ConditionsOpen Angle Glaucoma or Ocular HypertensionArmsDE-117 ophthalmic solution, Timolol ophthalmic solution
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 44 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Makoto AiharaOphthalmology, University of Tokyo, Tokyo, Japan.
Fenghe LuSanten Inc., 6401 Hollis Street, Suite 125, Emeryville, CA, 94608, USA. Fenghe.Lu@santen.com.
Hisashi KawataSanten Pharmaceutical Co., Ltd., Osaka, Japan.
Akihiro IwataSanten Pharmaceutical Co., Ltd., Osaka, Japan.
Noriko Odani-KawabataSanten Inc., 6401 Hollis Street, Suite 125, Emeryville, CA, 94608, USA.
Santen (Japan) · JPSanten (United States) · USThe University of Tokyo · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo assess the long-term safety and efficacy of omidenepag isopropyl (OMDI) 0.002% (a first-in-class, selective, non-prostaglandin, prostanoid EP2 receptor agonist), alone or administered concomitantly with timolol 0.5%, in patients with open-angle glaucoma (OAG, including normal-tension and exfoliation glaucoma) or ocular hypertension (OHT). STUDY

designOpen-label, multicenter, Phase 3 study (NCT02822729).

methodsPatients aged ≥ 20 years, with OAG or OHT, and a baseline diurnal intraocular pressure (IOP) ≥ 16- < 22 mmHg (Group 1) or ≥ 22- ≤ 34 mmHg (Groups 2 and 3) were enrolled. All patients (N = 125) received OMDI 0.002% once daily. Group 3 also received timolol 0.5% twice daily. IOP was measured at baseline and at Weeks 2, 4, 8, 12, 26, 40, and 52.

resultsSignificant reductions in mean diurnal IOP from baseline occurred at every visit (P < 0.0001). Mean ± SE diurnal IOP reduction at Week 52 was -3.7 ± 0.3 mmHg (Group 1), -5.6 ± 0.5 mmHg (Group 2), and -8.4 ± 0.6 mmHg (Group 3). Most adverse events (AEs) were mild, and no serious treatment-related AEs were reported. Conjunctival hyperemia (incidence: monotherapy [Groups 1 and 2], 18.8%; concomitant [Group 3], 45.0%) and macular edema (ME)/cystoid macular edema (CME) (incidence: monotherapy, 11.8%; concomitant, 15.0%) occurred most frequently. All treatment-related ME/CME cases occurred in pseudophakic eyes and responded to standard-of-care treatment and study drug discontinuation.

conclusionsIn this study, OMDI 0.002%, alone or administered concomitantly with timolol 0.5%, resulted in sustained IOP reduction over 52 weeks in patients with OAG or OHT. Concomitant treatment resulted in increased efficacy and increased incidence of conjunctival hyperemia.

Indexed as

Glaucoma, Open-AngleOcular HypertensionAntihypertensive AgentsDouble-Blind MethodGlycineHumansIntraocular PressureOphthalmic SolutionsPyrazolesPyridinesTimololTreatment OutcomeAntihypertensive AgentsGlycineomidenepag isopropylOphthalmic SolutionsPyrazolesPyridinesTimololEP2 receptor agonistGlaucomaOcular hypertensionOmidenepag isopropylPhase 3

Identifiers

PMID34495425
OpenAlexW3197069414

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.