COMMENTARY

Ranibizumab vs Laser in Diabetic Macular Edema

Kanish Mirchia, MBBS; Sophie J. Bakri, MD

Disclosures

August 06, 2014

A Randomized Trial to Assess Functional and Structural Effects of Ranibizumab Versus Laser in Diabetic Macular Edema (The LUCIDATE Study)

Comyn O, Sivaprasad S, Peto T, et al
Am J Ophthalmol. 2014;157:960-970

The LUCIDATE Study

The treatment goal for diabetic macular edema (DME) is to halt the progression of disease and to stabilize visual acuity. This has traditionally been accomplished with laser photocoagulation. Recent multicenter studies, including both phase 2 (RESOLVE, READ-2, RISE, and RIDE) and phase 3 (RESTORE and DRCR.net protocol 1) trials, suggest that treatment with the anti-vascular endothelial growth factor (VEGF) drug ranibizumab make it possible to improve or partially restore lost visual acuity. Most of these studies used best corrected visual acuity (BCVA) as the primary endpoint.

The LUCIDATE study, however, looked at the structural and visual outcomes in patients with DME after treatment with ranibizumab or laser photocoagulation. This was a 48-week, single-center, randomized, single-masked, prospective study in 33 patients with DME. The patients had baseline BCVA ranging from 55 (20/30) to 79 (20/80) Early Treatment Diabetic Retinopathy Study (ETDRS) letters, and central subfield thickness > 300 µm.

Patients were randomly assigned to 2 treatment groups, in a 2:1 ratio: (1) ranibizumab (Lucentis®) given at baseline, 4 weeks, and 8 weeks, then every 4 weeks as needed, or (2) macular laser photocoagulation performed at baseline, then every 12 weeks as needed.

Detailed functional and structural endpoints, as well as safety outcomes, were evaluated at baseline and then at 12, 24, and 48 weeks.

The functional endpoints were:

  • BCVA according to ETDRS guidelines;

  • Microperimetric retinal sensitivity (4° and 12°);

  • Color contrast threshold sensitivity (Protan and Tritan);

  • Pattern electroretinography (ERG; positive waveform at 50 ms, negative component of waveform at 95 ms);

  • Multifocal ERG; and

  • Full-field ERG.

The structural endpoints were:

  • Optical coherence tomography (OCT; macular thickness and volume in 9 ETDRS subfields) and

  • 4-field fundus photography.

The safety endpoints were:

  • Adverse events (ocular and nonocular);

  • Foveal avascular zone size; and

  • Perifoveal capillary loss.

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