Evidence map›Paper›PMID 36399237›Full record

ArticleOphthalmology and therapy2023

Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies.

Steven Yeh, Christopher R Henry, Barry Kapik, Thomas A Ciulla

2 registry-linked trialsOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Ophthalmology and therapy, 2023. 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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.6field-weighted citation impact, top 17% 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.

NCT02595398 phase3completednot on this map

A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis

TypeinterventionalSponsorClearside Biomedical, Inc.Ran2015 to 2018Enrolled160ConditionsUveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, IntermediateArms4mg CLS-TA Suprachoriodal Injection, Sham Procedure
NCT03097315 phase3completednot on this map

Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis

TypeinterventionalSponsorClearside Biomedical, Inc.Ran2017 to 2018Enrolled38ConditionsUveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, IntermediateArms4 mg CLS-TA Suprachoriodal Injection
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Review
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

4 authors at 3 institutions in 1 country.

Steven YehTruhlsen Eye Institute, University of Nebraska Medical Center, Omaha, NE, USA.ORCID http://orcid.org/0000-0002-5417-7771
Christopher R HenryRetina Consultants of Texas, Houston, TX, USA.ORCID http://orcid.org/0000-0003-4011-3758
Barry KapikClearside Biomedical, Inc., 900 North Point Parkway, Suite 200, Alpharetta, GA, 30005, USA.ORCID http://orcid.org/0000-0001-9655-7169
Thomas A CiullaClearside Biomedical, Inc., 900 North Point Parkway, Suite 200, Alpharetta, GA, 30005, USA. thomas.ciulla@clearsidebio.com.ORCID http://orcid.org/0000-0001-5557-6777
Clearside Biomedical (United States) · USMethodist Hospital · USUniversity of Nebraska Medical Center · US

Funding

Bausch + Lomb Funding for editorial/writing assistanceBausch + Lomb Payment for rapid service feeClearside Biomedical, Inc. Study funding
6 · The paper itself

Abstract

introductionMacular edema, a common complication of uveitis, may result in vision loss. The aim of this analysis was to report integrated phase 3 trial data for triamcinolone acetonide injectable suspension for suprachoroidal use (SCS-TA) in the treatment of macular edema secondary to noninfectious uveitis using strict inclusion criteria.

methodsThis analysis included patients with central subfield thickness (CST) ≥ 300 µm and best-corrected visual acuity (BCVA) of ≥ 5 and ≤ 70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at both screening and baseline who received ≥ 1 study treatment in either PEACHTREE (randomized, double-masked SCS-TA or sham control) or AZALEA (open-label SCS-TA). Patients received SCS-TA 4.0 mg (0.1 ml of 40 mg/ml) or control at baseline and week 12.

resultsIn the SCS-TA group (n = 95), 47.4% of patients gained ≥ 15 ETDRS letters from baseline to week 24 versus 16.7% of patients in the control group (n = 60; P < 0.001). Mean change in BCVA in the SCS-TA group was 9.6 letters at week 4 and 13.9 letters at week 24. CST also improved rapidly in the SCS-TA group (mean change: - 158.4 µm at week 4), with sustained reduction throughout the study (mean change: - 163.9 µm at week 24 versus - 19.3 µm in the control group; P < 0.001). No treatment-related serious adverse events (AEs) were reported. Incidence of AEs pertaining to elevated intraocular pressure was 12.6% and 15.0% in the SCS-TA and control groups, respectively; incidence of cataract formation/worsening AEs was 7.4% and 6.7%, respectively.

conclusionIn this integrated analysis utilizing strict inclusion criteria, SCS-TA was found effective in the treatment of patients with macular edema associated with noninfectious uveitis and was generally well tolerated.

trial registrationClinicalTrials.gov identifier: NCT02595398, NCT03097315.

Indexed as

Central subfield thicknessMacular edemaSuprachoroidalTriamcinolone acetonideUveitis

Identifiers

PMID36399237
PMCPMC9834475
OpenAlexW4309360696

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.