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Rubens Siqueira, Renato Cunha, Andre Messias, Armando Cunha, Silvia Fialho, Rodrigo Jorge; Retinal Safety and Efficacy of a Dexamethasone Biodegradable Implant to Treat Macular Edema Associated to Retinal Vein Occlusion: A Phase I/II Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2013;54(15):5066.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the safety and efficacy of a biodegradable implant containing 350 µg of dexamethasone (DDS-25 gauge) for the treatment of macular edema associated to retinal vein occlusion (vME)
Prospective, nonrandomized, open-label, phase I/II clinical trial, including 10 patients (n=10 eyes) with chronic vME, showing ETDRS best-correct visual acuity (BCVA) of 20/50 or worse. Evaluations included BCVA, spectral-domain optical coherence tomography (OCT - Spectralis Heidelberg Engineering) for determination of central macular thickness (CMT), full-field electroretinography (ISCEV standard ERG), kinetic visual field (Octopus 900), and fluorescein and indocyanine green angiography. Evaluations were performed at baseline, and 1, 4, 12 and 24 weeks after intravitreal DDS-25 insertion.
The mean ± SE (range) CMT at baseline was 461.2 ± 41.3 μm (288 to 701 µm), and 439.6 ± 40.4 µm (259 to 631 µm), 442.5 ± 44.6 µm (255 to 632 µm), 354.6 ± 31.2 µm (228 to 537 µm), 316.5 ± 26.4 µm (226 to 441 µm) at 1, 4, 12, and 24 weeks respectively. Showing a significant improvement of 144.7 ± 46.0 µm at 24 weeks (P=0.0059; ANOVA). BCVA improved significantly in 0.14 ± 0.06 logMAR (7 ETDRS letters) at 24 weeks (P=0.0248), with 6 patients improving between 1 to 4 ETRS lines. Mean rod b-wave amplitude was 265.4 ± 30.4 µV at baseline and 255.6 ± 32.6 µV at 4 weeks (P=0.375), and no significant changes were observed for any ERG parameters, visual fields or angiography during follow-up. Related adverse events included no significant IOP elevation of 3.2 ± 1.6 mmHg (P=0.071) at week 24.
Our data suggests that the DDS-25 is safe and efficient for the treatment of vME in a short follow up time (6 months). A larger prospective randomized study is warranted to confirm these preliminary findings.
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