Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1 - Summary - MDSpire
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Safety and Impact of Gildeuretinol Acetate on Retinal Atrophy in Stargardt Disease: Results From TEASE-1

  • By

  • Christine N. Kay

  • Leonide Saad

  • Gabrielle DeBartolomeo

  • Neil Bressler

  • Stephen H. Tsang

  • Kimberly Stepien

  • Paul Bernstein

  • Byron L. Lam

  • Ilyas Washington

  • Michael B. Gorin

  • TEASE-1 Study Group

  • Arsany Makkar

  • Hendrik Scholl

  • Mahmood Seyd Shah

  • Mandeep Singh

  • Shazia Khan

  • Mary Frey

  • Robert L. Roseman

  • Kaushik M. Hazariwala

  • Jing Zhang

  • Sarah Justus

  • Sophia Karen Park

  • Christine Xu

  • Thomas Connor

  • Dennis Han

  • Judy Kim

  • David Weinberg

  • William Wirostko

  • Kurt Pfeifer

  • Heather Toth

  • Krissa Packard

  • Eleanor Dorsey Veh

  • Vesper Williams

  • Kaitlin McKenney

  • Brittany Rego

  • Patricia Winter

  • Hannah Sheppard

  • Stephanie Moebius

  • Angela Urmanski

  • Amanda Daubert

  • Senad Novic

  • Potyra R. Rosa

  • Kimberley Wegner

  • Elizabeth Nuttall

  • Kelliann Farnsworth Ordonez

  • William C. Hubbard

  • Melissa Chandler

  • Becky Weeks

  • Donnell Creel

  • Steven Nusinowitz

  • Emma Stackpole

  • Anna Matynia,

  • Julliane Bacerdo

  • October 1, 2026

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Objective:

To assess the safety of daily oral gildeuretinol acetate and its effect on growth of retinal atrophic lesions in Stargardt disease (STGD).

Approach:
  • Design: TEASE-1 was a multicenter, double-masked, placebo-controlled phase 2 trial lasting 24 months, with randomized treatment groups, a crossover group, and natural-history cases.
  • Participants: The analysis included 50 randomized participants and 54 natural-history cases. Participants were at least 12 years old and had a clinical STGD diagnosis with an ABCA4 variant classified as disease-causing or likely disease-causing.
  • Treatment: Participants were assigned to daily oral gildeuretinol acetate at 14 mg or 24 mg, placebo, or crossover treatment (placebo in year 1 and gildeuretinol in year 2). The 24-mg group could switch to 14 mg after 12 months based on interim pharmacokinetic findings.
Key Findings:
  • The supplied context describes the study design and rationale but does not provide safety results or primary-endpoint estimates.
Interpretation:

Gildeuretinol acetate is a deuterium-enriched vitamin A acetate designed to suppress retinal vitamin A dimerization while retaining vitamin A’s other properties. The context does not report TEASE-1 outcome data, so its safety or effect on lesion growth cannot be summarized.

Limitations:
  • The provided article context ends before the natural-history cohort description is complete.
  • No adverse-event data, retinal atrophy measurements, or primary-endpoint results are included in the supplied context.
Sources:

Original Source(s)

Safety and Effects of Gildeuretinol Acetate on Retinal Atrophic Lesions in Stargardt Disease: The TEASE-1

  • by Christine N. Kay, Leonide Saad, Gabrielle DeBartolomeo, Neil Bressler, Stephen H. Tsang, Kimberly Stepien, Paul Bernstein, Byron L. Lam, Ilyas Washington, Michael B. Gorin, TEASE-1 Study Group, Arsany Makkar, Hendrik Scholl, Mahmood Seyd Shah, Mandeep Singh, Shazia Khan, Mary Frey, Robert L. Roseman, Kaushik M. Hazariwala, Jing Zhang, Sarah Justus, Sophia Karen Park, Christine Xu, Thomas Connor, Dennis Han, Judy Kim, David Weinberg, William Wirostko, Kurt Pfeifer, Heather Toth, Krissa Packard, Eleanor Dorsey Veh, Vesper Williams, Kaitlin McKenney, Brittany Rego, Patricia Winter, Hannah Sheppard, Stephanie Moebius, Angela Urmanski, Amanda Daubert, Senad Novic, Potyra R. Rosa, Kimberley Wegner, Elizabeth Nuttall, Kelliann Farnsworth Ordonez, William C. Hubbard, Melissa Chandler, Becky Weeks, Donnell Creel, Steven Nusinowitz, Emma Stackpole, Anna Matynia,, Julliane Bacerdo

  • October 1, 2026

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