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Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.

Publication ,  Journal Article
Diabetic Retinopathy Clinical Research Network, ; Writing Committee, ; Aiello, LP; Beck, RW; Bressler, NM; Browning, DJ; Chalam, KV; Davis, M ...
Published in: Ophthalmology
December 2011

OBJECTIVE: To describe the underlying principles used to develop a web-based algorithm that incorporated intravitreal anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) in a Diabetic Retinopathy Clinical Research Network (DRCR.net) randomized clinical trial. DESIGN: Discussion of treatment protocol for DME. PARTICIPANTS: Subjects with vision loss resulting from DME involving the center of the macula. METHODS: The DRCR.net created an algorithm incorporating anti-VEGF injections in a comparative effectiveness randomized clinical trial evaluating intravitreal ranibizumab with prompt or deferred (≥24 weeks) focal/grid laser treatment in eyes with vision loss resulting from center-involved DME. Results confirmed that intravitreal ranibizumab with prompt or deferred laser provides superior visual acuity outcomes compared with prompt laser alone through at least 2 years. Duplication of this algorithm may not be practical for clinical practice. To share their opinion on how ophthalmologists might emulate the study protocol, participating DRCR.net investigators developed guidelines based on the algorithm's underlying rationale. MAIN OUTCOME MEASURES: Clinical guidelines based on a DRCR.net protocol. RESULTS: The treatment protocol required real-time feedback from a web-based data entry system for intravitreal injections, focal/grid laser treatment, and follow-up intervals. Guidance from this system indicated whether treatment was required or given at investigator discretion and when follow-up should be scheduled. Clinical treatment guidelines, based on the underlying clinical rationale of the DRCR.net protocol, include repeating treatment monthly as long as there is improvement in edema compared with the previous month or until the retina is no longer thickened. If thickening recurs or worsens after discontinuing treatment, treatment is resumed. CONCLUSIONS: Duplication of the approach used in the DRCR.net randomized clinical trial to treat DME involving the center of the macula with intravitreal ranibizumab may not be practical in clinical practice, but likely can be emulated based on an understanding of the underlying rationale for the study protocol. Inherent differences between a web-based treatment algorithm and a clinical approach may lead to differences in outcomes that are impossible to predict. The closer the clinical approach is to the algorithm used in the study, the more likely the outcomes will be similar to those published. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

December 2011

Volume

118

Issue

12

Start / End Page

e5 / 14

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Ranibizumab
  • Randomized Controlled Trials as Topic
  • Ophthalmology & Optometry
  • Macular Edema
  • Laser Coagulation
  • Intravitreal Injections
  • Humans
 

Citation

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Diabetic Retinopathy Clinical Research Network, ., Writing Committee, ., Aiello, L. P., Beck, R. W., Bressler, N. M., Browning, D. J., … Topping, T. M. (2011). Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema. Ophthalmology, 118(12), e5-14. https://doi.org/10.1016/j.ophtha.2011.09.058
Diabetic Retinopathy Clinical Research Network, Trexler M., Trexler M. Writing Committee, Lloyd Paul Aiello, Roy W. Beck, Neil M. Bressler, David J. Browning, K. V. Chalam, et al. “Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.Ophthalmology 118, no. 12 (December 2011): e5-14. https://doi.org/10.1016/j.ophtha.2011.09.058.
Diabetic Retinopathy Clinical Research Network, Writing Committee, Aiello LP, Beck RW, Bressler NM, Browning DJ, et al. Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema. Ophthalmology. 2011 Dec;118(12):e5-14.
Diabetic Retinopathy Clinical Research Network, Trexler M., et al. “Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema.Ophthalmology, vol. 118, no. 12, Dec. 2011, pp. e5-14. Pubmed, doi:10.1016/j.ophtha.2011.09.058.
Diabetic Retinopathy Clinical Research Network, Writing Committee, Aiello LP, Beck RW, Bressler NM, Browning DJ, Chalam KV, Davis M, Ferris FL, Glassman AR, Maturi RK, Stockdale CR, Topping TM. Rationale for the diabetic retinopathy clinical research network treatment protocol for center-involved diabetic macular edema. Ophthalmology. 2011 Dec;118(12):e5-14.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

December 2011

Volume

118

Issue

12

Start / End Page

e5 / 14

Location

United States

Related Subject Headings

  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Ranibizumab
  • Randomized Controlled Trials as Topic
  • Ophthalmology & Optometry
  • Macular Edema
  • Laser Coagulation
  • Intravitreal Injections
  • Humans