PMID- 32173113
OWN - NLM
STAT- MEDLINE
DCOM- 20201207
LR  - 20201214
IS  - 1549-4713 (Electronic)
IS  - 0161-6420 (Linking)
VI  - 127
IP  - 7
DP  - 2020 Jul
TI  - Efficacy and Safety of Suprachoroidal CLS-TA for Macular Edema Secondary to 
      Noninfectious Uveitis: Phase 3 Randomized Trial.
PG  - 948-955
LID - S0161-6420(20)30011-7 [pii]
LID - 10.1016/j.ophtha.2020.01.006 [doi]
AB  - PURPOSE: Injection of pharmacotherapy into the suprachoroidal space, between the 
      sclera and choroid, is an alternative delivery technique developed with the 
      rationale of providing higher drug concentrations to posterior ocular structures 
      compared with other intraocular and periocular injection procedures. This study 
      was conducted to evaluate the safety and efficacy of suprachoroidally injected 
      triamcinolone acetonide formulation (CLS-TA), a suspension of triamcinolone 
      acetonide, in improving vision among patients with noninfectious uveitis 
      complicated by macular edema (ME). DESIGN: Phase 3 masked, randomized trial. 
      PARTICIPANTS: One hundred sixty patients with ME secondary to noninfectious 
      uveitis. Patients were required to have a best-corrected visual acuity (BCVA) of 
      5 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters (Snellen 
      equivalent, 20/800) and 70 or fewer ETDRS letters read (Snellen equivalent, 
      20/40) in the study eye. METHODS: Patients were randomized 3:2 to 
      suprachoroidally injected CLS-TA or sham treatment, with administrations at day 0 
      and week 12. MAIN OUTCOME MEASURES: The primary end point was improvement from 
      baseline of 15 or more ETDRS letters in BCVA at week 24. The secondary end point 
      was reduction from baseline in central subfield thickness (CST) at week 24. 
      RESULTS: In the CLS-TA arm, 47% of patients gained 15 or more ETDRS letters in 
      BCVA versus 16% in the control arm (P < 0.001), meeting the primary end point. 
      Mean reductions in CST from baseline were 153 mum versus 18 mum (P < 0.001). No 
      serious adverse events (AEs) related to treatment were reported. 
      Corticosteroid-associated AEs of elevated intraocular pressure occurred in 11.5% 
      and 15.6% of the CLS-TA and control groups, respectively. Cataract AE rates were 
      comparable (7.3% and 6.3%, respectively). CONCLUSIONS: Patients in the CLS-TA 
      study arm experienced clinically significant improvement in vision relative to 
      the sham procedure, demonstrating the efficacy of suprachoroidal injection of 
      CLS-TA for the treatment of ME in a vision-threatening disorder.
CI  - Copyright (c) 2020 American Academy of Ophthalmology. Published by Elsevier Inc. 
      All rights reserved.
FAU - Yeh, Steven
AU  - Yeh S
AD  - Emory Eye Center, Emory University School of Medicine, Atlanta, Georgia; Emory 
      Global Health Institute, Emory University, Atlanta, Georgia. Electronic address: 
      syeh3@emory.edu.
FAU - Khurana, Rahul N
AU  - Khurana RN
AD  - Northern California Retina Vitreous Associates, Mountain View, California; 
      Department of Ophthalmology, University of California, San Francisco, San 
      Francisco, California.
FAU - Shah, Milan
AU  - Shah M
AD  - Midwest Eye Institute, Indianapolis, Indiana.
FAU - Henry, Christopher R
AU  - Henry CR
AD  - Retina Consultants of Houston, Houston, Texas; Blanton Eye Institute, Houston 
      Methodist Hospital, Houston, Texas.
FAU - Wang, Robert C
AU  - Wang RC
AD  - Texas Retina Associates, Dallas, Texas.
FAU - Kissner, Jennifer M
AU  - Kissner JM
AD  - Clearside Biomedical, Inc., Alpharetta, Georgia.
FAU - Ciulla, Thomas A
AU  - Ciulla TA
AD  - Clearside Biomedical, Inc., Alpharetta, Georgia.
FAU - Noronha, Glenn
AU  - Noronha G
AD  - Clearside Biomedical, Inc., Alpharetta, Georgia.
CN  - PEACHTREE Study Investigators
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20200110
PL  - United States
TA  - Ophthalmology
JT  - Ophthalmology
JID - 7802443
RN  - 0 (Glucocorticoids)
RN  - F446C597KA (Triamcinolone Acetonide)
SB  - IM
MH  - Choroid
MH  - Female
MH  - Glucocorticoids/administration & dosage
MH  - Humans
MH  - Injections, Intraocular
MH  - Macular Edema/diagnosis/*drug therapy/etiology
MH  - Male
MH  - Middle Aged
MH  - Tomography, Optical Coherence/methods
MH  - Treatment Outcome
MH  - Triamcinolone Acetonide/*administration & dosage
MH  - Uveitis/*complications/diagnosis/drug therapy
MH  - *Visual Acuity
EDAT- 2020/03/17 06:00
MHDA- 2020/12/15 06:00
CRDT- 2020/03/17 06:00
PHST- 2019/05/20 00:00 [received]
PHST- 2019/12/28 00:00 [revised]
PHST- 2020/01/03 00:00 [accepted]
PHST- 2020/03/17 06:00 [pubmed]
PHST- 2020/12/15 06:00 [medline]
PHST- 2020/03/17 06:00 [entrez]
AID - S0161-6420(20)30011-7 [pii]
AID - 10.1016/j.ophtha.2020.01.006 [doi]
PST - ppublish
SO  - Ophthalmology. 2020 Jul;127(7):948-955. doi: 10.1016/j.ophtha.2020.01.006. Epub 
      2020 Jan 10.