July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Suprachoroidal Space Alterations after Delivery of Triamcinolone Acetonide: Post-Hoc Analysis of the Phase 1/2 HULK Study of Patients with Diabetic Macular Edema
Author Affiliations & Notes
  • Shaun Ian Retief Lampen
    Retina Consultants of Houston, Houston, Texas, United States
  • Rahul N. Khurana
    Northern California Retina Vitreous Association, Mountain View, California, United States
  • David M Brown
    Retina Consultants of Houston, Houston, Texas, United States
    Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas, United States
  • Charles Clifton Wykoff
    Retina Consultants of Houston, Houston, Texas, United States
    Blanton Eye Institute, Houston Methodist Hospital & Weill Cornell Medical College, Houston, Texas, United States
  • Footnotes
    Commercial Relationships   Shaun Lampen, None; Rahul Khurana, Allergan (F), Allergan (C), Clearside Biomedical (F), Genentech (C), Genentech (R), Regeneron (F), Regeneron (C), Regeneron (R), Santen (F), Santen (C); David Brown, None; Charles Wykoff, Allergan, Inc. (F), Allergan, Inc. (C), Allergan, Inc. (R), Apellis Pharmaceutical (F), Bayer AG (C), Clearside Biomedical, Inc. (F), Clearside Biomedical, Inc. (C), Genentech, Inc. (F), Genentech, Inc. (C), Novartis International AG (F), Ophthotech Corporation (F), Regeneron Pharmaceuticals, Inc. (F), Regeneron Pharmaceuticals, Inc. (C), Regeneron Pharmaceuticals, Inc. (R), Roche Holding AG (F), Roche Holding AG (C)
  • Footnotes
    Support  Research grant from Clearside Biomedical, Inc., Alpharetta, GA, USA
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1096. doi:
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      Shaun Ian Retief Lampen, Rahul N. Khurana, David M Brown, Charles Clifton Wykoff; Suprachoroidal Space Alterations after Delivery of Triamcinolone Acetonide: Post-Hoc Analysis of the Phase 1/2 HULK Study of Patients with Diabetic Macular Edema. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1096.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : Delivery of pharmaceuticals into the suprachoroidal (SC) space, a potential space between the choroid and sclera, is a promising approach to the management of retinal diseases. A deeper understanding of alterations induced in the SC space is needed following suprachoroidal delivery in humans.

Methods : Subjects in the prospective HULK trial (IND 115683; NCT02949024) receiving SC triamcinolone acetonide (0.1 cc, 4 mg, CLS-TA, Clearside Biomedical) for diabetic macular edema (DME) were imaged with anterior segment spectral-domain optical coherence tomography (AS-OCT). When imaged, line (15°, 768 A-scans) & volume (15° x 5°, 41 sections, 768 A-scans) scans of 8 pre-defined quadrants were captured. AS-OCT were obtained before & 30 minutes following SC CLS-TA. SC width was measured using calipers (Figure). A 1:1 pixel to micron ratio was applied.

Results : AS-OCT of study (n=14) & fellow eyes (n=10) (no SC injection) were captured from 17 visits. Among all subjects, mean time from last SC delivery to final AS-OCT was 4.8 (range: 1.0 – 9.9) months. At the final imaging session, SC width was not significantly different in study eyes (8.4 µm) compared to fellow eyes (8.1 µm) (P=0.698). Three imaging sessions, involving 2 patients, were performed at the time of SC CLS-TA delivery: prior to CLS-TA delivery, mean SC width was 9.9 µm, and mean SC width increased by a mean of 65.1 µm to 75.1 µm (P<0.001) following SC CLS-TA. Mean SC width increased to 17.2 µm, 90.7 µm, 112.3 µm and 56.8 µm at 2, 3, 4, and 5 mm posterior to Schlemm’s canal, respectively. No significant increase in SC width was observed ≤2 mm posterior to Schlemm’s canal (P=0.130). Mean SC width returned to 14.9 µm at follow-up 1 month later (P=0.221).

Conclusions : SC injection of CLS-TA in eyes of patients with DME resulted in measurable expansion of the width of the SC space within 30 minutes. By 1 month after delivery, the SC width had normalized & no anatomic differences were observed compared to fellow eyes used as controls.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

A. Six 1 mm calipers starting at the posterior margin of Schlemm’s canal measuring the sclera (blue), choroid (orange), & area of interest (green) are marked. SC width was calculated by subtracting the width of the sclera & choroid from the area of interest. B. Expanded SC space after delivery of CLS-TA indicated by blue arrow.

A. Six 1 mm calipers starting at the posterior margin of Schlemm’s canal measuring the sclera (blue), choroid (orange), & area of interest (green) are marked. SC width was calculated by subtracting the width of the sclera & choroid from the area of interest. B. Expanded SC space after delivery of CLS-TA indicated by blue arrow.

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