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Triamcinolone versus inner-limiting membrane peeling in persistent diabetic macular edema (TIME study): design issues and implications

  • Clinical Investigation
  • Published:
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Abstract

Aim

Treatment options for persistent diabetic macular edema remain disappointing. ILM peeling and intravitreal triamcinolone have been successfully used in several case series; however, there is no evidence that one of these options is superior for specific groups of patients. The triamcinolone versus ILM peeling in diabetic macular edema study (TIME-study) is designed to investigate the efficacy of these two treatments in patients with persistent diabetic macular edema.

Methods

Patients with persistent diabetic macular edema are randomised to either the control group (no treatment), ppV + ILM peeling, or triamcinolone (4 mg) injection. One hundred thirty-five patients are to be recruited per group and followed-up for one year. The main endpoints are defined as change in visual acuity (VA) at 12 months compared to baseline and the change in retinal thickness after 3 months follow-up. Secondary endpoints include differences in the functional success and anatomical success and the effect of the treatment on the patient’s quality of life. Twelve institutions (28 surgeons) in 3 European countries agreed to contribute to the study.

Results

The design issues and implications of the study are described.

Conclusions

The TIME study is the first randomised prospective clinical trial to investigate the effectiveness of the two treatment methods. The results of this study should enable physicians to improve therapy and to select cases according to the most promising treatment option.

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Acknowledgement

This study is funded by the Deutsche Forschungsgemeinschaft (DFG Jo 324/6-1 (Emmy Noether Career Development Award), DFG Jo 324/7-1, and DFG Hi 541/3-1). The authors wrote this report on behalf of the TIME Study group. A complete list of participants is given in the Appendix.

Author information

Authors and Affiliations

  1. Department of Ophthalmology, University Hospital Duesseldorf, University of Duesseldorf, Moorenstraße 5, 40225, Duesseldorf, Germany

    Antonia M. Joussen

  2. Institute of Medical Statistics, RWTH Aachen, Aachen, Germany

    Claudia Weiss, Diana Bauer & Ralf-Dieter Hilgers

Authors
  1. Antonia M. Joussen
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  2. Claudia Weiss
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  3. Diana Bauer
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  4. Ralf-Dieter Hilgers
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Consortia

on behalf of the TIME Study group

Corresponding author

Correspondence to Antonia M. Joussen.

Appendix

Appendix

Participants

Principal investigators: AM Joussen (Düsseldorf), B Kirchhof (Köln), RD Hilgers (Aachen)

Endpoint Committee: AM Joussen, B Kirchhof, RD Hilgers, KD Lemmen

Biostatisticians and data managers: RD Hilgers, D Bauer

Surgeons (alphabetic order):

Agostini (Freiburg), Bornfeld (Essen), Bunse (Kiel), Binder (Wien), Dahlke (Köln), Foja (Leipzig), Gandorfer (München), Groenewald (Liverpool), Hansen (Freiburg), Heimann (Liverpool), Hoerauf (Lübeck), Jochmann (Leipzig), Joussen (Düsseldorf), Kampik (München), Kirchhof (Köln), Kohen (Leipzig), Lommatzsch (Münster), Meier (Leipzig), Müller (Lübeck), Pauleikhoff (Münster), Pearce (Liverpool), Requadt (Hannover), Roider (Kiel), Stolba (Wien), Ulbig (München), Wiechens (Hannover), Wiedemann (Leipzig), Wong (Liverpool)

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Joussen, A.M., Weiss, C., Bauer, D. et al. Triamcinolone versus inner-limiting membrane peeling in persistent diabetic macular edema (TIME study): design issues and implications. Graefes Arch Clin Exp Ophthalmol 245, 1781–1787 (2007). https://doi.org/10.1007/s00417-007-0640-3

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  • DOI: https://doi.org/10.1007/s00417-007-0640-3

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