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Clinical Trial
. 2018 Feb:186:144-151.
doi: 10.1016/j.ajo.2017.11.020. Epub 2017 Dec 2.

Choroidal Changes After Suprachoroidal Injection of Triamcinolone Acetonide in Eyes With Macular Edema Secondary to Retinal Vein Occlusion

Affiliations
Clinical Trial

Choroidal Changes After Suprachoroidal Injection of Triamcinolone Acetonide in Eyes With Macular Edema Secondary to Retinal Vein Occlusion

Alex S Willoughby et al. Am J Ophthalmol. 2018 Feb.

Abstract

Purpose: To evaluate choroidal and suprachoroidal changes following suprachoroidal injection of triamcinolone acetonide injectable suspension (CLS-TA), in eyes with macular edema due to retinal vein occlusion (RVO).

Design: Prospective cohort study within a randomized, controlled phase 2 clinical trial.

Methods: Enhanced depth imaging optical coherence tomography (EDI-OCT) images were analyzed from 38 eyes of 38 treatment-naïve patients with macular edema due to RVO, enrolled in the prospective Suprachoroidal Injection of Triamcinolone Acetonide with Intravitreal Aflibercept in Subjects with Macular Edema Due to Retinal Vein Occlusion (TANZANITE) study who received either a suprachoroidal injection of CLS-TA with an intravitreal injection of aflibercept (combination arm) or only an intravitreal injection of aflibercept (monotherapy arm), followed by monthly intravitreal aflibercept injections in both arms based on pro re nata criteria.

Results: Macular choroidal thickness measured to the outer choroidal vessel lumen (vascular choroidal thickness, VCT), outer choroid stroma (stromal choroidal thickness, SCT), or inner scleral border (total choroidal thickness, TCT) showed no significant changes over 3 months in both study arms (P = .231-.342). Eyes that received combination therapy showed a trend toward thickening of the suprachoroidal space (SCS) compared with monotherapy alone (13.4 μm vs 5.3 μm at 3 months; P = .077). In the 15 eyes that demonstrated a visible SCS at baseline, the SCS expanded significantly after suprachoroidal CLS-TA injection (16.2 μm to 27.8 μm at 3 months; P = .033).

Conclusions: Suprachoroidal injection of CLS-TA does not alter choroidal thickness in eyes with macular edema due to RVO, but may result in expansion of the SCS.

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Conflict of interest statement

Conflict of Interests:

AW: none

VV: none

GN: employee, patents, and equity at Clearside

RD: equity and employee relationship at EyeKor Inc.

DC: none

SF: patents in OCT imaging and analysis

GY: grants from Alcon, ARVO Foundation, E Matilda Ziegler Foundation, Genentech and personal fees for consultancy from Alimera, Allergan, Carl Zeiss Meditec, and Southern California Desert Retina.

Figures

Figure 1
Figure 1
Semi-automated choroidal segmentation of EDI-OCT images before and after suprachoroidal triamcinolone acetonide and intravitreal aflibercept injection in an eye with ME due to RVO. Images are shown before injection (top row), and at 1 month (second row), 2 months (third row), and 3 months (bottom row) after treatment, with (left column) and without (right column) segmentation boundaries, including the inner limiting membrane (white line), RPE/Bruch’s membrane complex (purple line), vascular choroidal thickness boundary (blue line), stromal choroidal thickness boundary (yellow line), and total choroidal thickness boundary (green line). The fovea is labeled with a yellow asterisk.
Figure 2
Figure 2
Change in mean central choroidal thickness in eyes treated with suprachoroidal triamcinolone acetonide and intravitreal aflibercept (combination arm) versus intravitreal aflibercept only (monotherapy arm). Abbreviations: VCT, vascular choroidal thickness; SCT, stromal choroidal thickness; TCT, total choroidal thickness; SCS, suprachoroidal space; IVT, intravitreal, TA, triamcinolone acetonide)
Figure 3
Figure 3
Receiver operating characteristic (ROC) curve using Youden’s Index (YI) to measure the threshold for determining the presence or absence of a visible suprachoroidal space.
Figure 4
Figure 4
Change in mean central choroidal thickness in eyes with a visible suprachoroidal space treated with suprachoroidal triamcinolone acetonide, and intravitreal aflibercept (combination arm) versus aflibercept only (monotherapy arm). Abbreviations: VCT, vascular choroidal thickness; SCT, stromal choroidal thickness; TCT, total choroidal thickness; SCS, suprachoroidal space; IVT, intravitreal; CLS-TA, preservative-free, terminally sterilized triamcinolone acetonide.

Comment in

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