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

At a Glance

CategoryDetail
ConditionClinical topic addressed by the source article: Safety and Impact of Gildeuretinol Acetate on Retinal Atrophy in Stargardt Disease
Key MechanismsABCA4 variants are believed to cause aberrant retinal vitamin A dimerization, resulting in toxic bisretinoids. Gildeuretinol acetate is deuterium-enriched vitamin A acetate designed to selectively suppress retinal vitamin A dimerization while retaining vitamin A’s other properties; preclinical studies reported correction of aberrant dimerization and rescue of the Stargardt phenotype in mouse models.
Target PopulationPopulation described in the source article.
Care SettingA 24-month, multicenter, double-masked, placebo-controlled randomized clinical trial conducted at seven US sites; the article reports TEASE-1 safety outcomes and primary-end-point results.

Key Highlights

  • STGD causes progressive retinal atrophy and visual disturbances; the source states that no approved therapies were available at the time described.
  • TEASE-1 assessed daily oral gildeuretinol acetate for safety and effects on retinal atrophic lesion growth.
  • The analysis included 50 randomized participants and 54 natural-history cases.
  • Randomized regimens included 14 mg or 24 mg daily, placebo, and a crossover cohort receiving placebo in year 1 and gildeuretinol in year 2.
  • The protocol allowed the 24-mg regimen to be stopped and substituted with 14 mg after 12 months if a masked interim pharmacokinetic analysis showed similar vitamin A replacement; confirm whether the article reports that this criterion was met.

Guideline-Based Recommendations

Diagnosis

  • Trial eligibility required a clinical diagnosis of STGD and confirmation of at least one ABCA4 sequence variation classified as disease-causing or likely disease-causing.
  • Participants needed at least one eye with well-demarcated regions of markedly decreased fundus autofluorescence; any visual acuity was permitted.

Management

  • The study evaluated once-daily oral gildeuretinol acetate; it does not provide a general treatment recommendation.
  • Participants were instructed to consume no more than three servings of vitamin A daily and to avoid vitamin A or carotene supplements and liver-based products.
  • AREDS and AREDS2 supplements were prohibited during the study; users completed a 30-day washout before randomization.

Monitoring & Follow-up

  • Study visits were scheduled at week 4 (optional), week 8, and months 6, 12, 18, and 24.
  • A masked interim pharmacokinetic analysis during year 1 was planned to assess whether vitamin A replacement was similar with 14-mg and 24-mg daily regimens.

Risks

  • The supplied text identifies safety as a study outcome but does not provide specific adverse-event findings.
  • STGD is associated with progressive vision loss and visual disturbances, including reduced visual acuity, visual fields, and night vision, chromatopsia, glare, and visual hallucinations.

Patient & Prescribing Data

TEASE-1 eligibility included people aged 12 years or older with STGD, qualifying fundus autofluorescence findings, and genetic confirmation as specified in the protocol.

Participants were randomized to daily oral gildeuretinol acetate at 14 mg or 24 mg, placebo, or a crossover regimen. The protocol allowed the 24-mg group to switch to 14 mg after 12 months following interim pharmacokinetic analysis. The supplied text does not report clinical outcome estimates or detailed safety results.

Clinical Best Practices

  • Interpret the reported findings as TEASE-1 data; the article states that it presents data exclusively from TEASE-1 despite the broader ClinicalTrials.gov identifier covering multiple TEASE studies.
  • The trial protocol was approved by site institutional review boards, and participants provided written informed consent before screening or study procedures.
  • The study followed the Declaration of Helsinki, ICH E6 Good Clinical Practice, and applicable regulations; reporting adhered to CONSORT.

Related Resources & Content

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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