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Ophthalmology. 2014 Oct;121(10):1904-14. doi: 10.1016/j.ophtha.2014.04.024. Epub 2014 Jun 4.

Three-year, randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema.

Collaborators (152)

Abujamra S, Acton J, Ali F, Antoszyk A, Augustin AJ, Awh CC, Barak A, Bartz-Schmidt KU, Baumal CR, Belfort R Jr, Bhende M, Boyer DS, Bridges WZ Jr, Brown DM, Carmichael T, Carnevale K, Casella AM, Chang T, Chechik D, Chen SN, Chong LP, Chong V, Corwin J, Creuzot-Garcher C, Cruess A, Daniell M, de Avila MP, Vieira de Moraes H Jr, Devenyi RG, Doft BH, Donaldson M, Dreyer R, Eliott D, Engel HM, Ernest J, Essman TF, Falcone PM, Fekrat S, Ferencz JR, Ferreira JL, Figueira J, Fiser I, Foster B, Fox GM, Freeman WR, Garg S, Gillies M, Glaser D, Goldstein BG, Gomes AM, Gonder JR, Gopal L, Gous P, Gupta A, Gupta A, Halperin L, Han D, Hariprasad SM, Holz FG, Kaiser P, Kalvodova B, Katz B, Katz RS, Kecik D, Kellaway J, Klemperer I, Kuppermann B, Lanzetta P, Lattanzio R, Lee WK, Lehr J, Leys M, Loose I, Lotery A, Lu DW, McCartney P, Majji AB, Martinez JA, Massin P, Maturi RK, Menchini U, Menon G, Michels M, Midena E, Miller J Jr, Mitchell P, Moisseiev J, Morse L, Navarro R, Nemeth J, Newland H, Newsom R, Nichols J, Orellana J, Orzalesi N, Paranhos A Jr, Park R, Park S, Parodi MB, Pavan PR, Peace J, Perez-Ortiz DJ, Pollack A, Ramaswamy K, Ratnakaram R, Ravalico G, Rehak J, Rezaei K, Rizzo S, Rodriguez-Alvira FJ, Romanet JP, Rose S, Rosen RB, Rossetti L, Ruiz-Moreno JM, Sadda S, Sall K, Sandner D, Sanz AF, Sartani G, Schmickler S, Schwartz SD, Sharma Y, Sheu SJ, Singer M, Sivaprasad S, Soubrane G, Soucek P, Souied EH, Staurenghi G, Studnicka J, Suarez-Figueroa M, Takahashi WY, Tognetto D, Tsai PL, Ulanski LJ 2nd, Uy H, Varano M, Veith M, Vicha I, Viola F, Visser L, Weinberger D, Wing GL, Wong E, Wong T, Wylegala E, Yan J, Yoon YH, Young LH, Yu HG, Zimmer-Galler IE.

Author information

1
Retina-Vitreous Associates Medical Group, Los Angeles, California. Electronic address: vitdoc@aol.com.
2
Asan Medical Center, University of Ulsan, Seoul, South Korea.
3
Vision Institute, Federal University of São Paulo, São Paulo, Brazil.
4
University Vita-Salute, Hospital San Raffaele, Milan, Italy.
5
Midwest Eye Institute, Indianapolis, Indiana.
6
Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.
7
Allergan, Inc, Irvine, California.

Abstract

PURPOSE:

To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex, DEX implant) 0.7 and 0.35 mg in the treatment of patients with diabetic macular edema (DME).

DESIGN:

Two randomized, multicenter, masked, sham-controlled, phase III clinical trials with identical protocols were conducted. Data were pooled for analysis.

PARTICIPANTS:

Patients (n = 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of ≥300 μm by optical coherence tomography.

METHODS:

Patients were randomized in a 1:1:1 ratio to study treatment with DEX implant 0.7 mg, DEX implant 0.35 mg, or sham procedure and followed for 3 years (or 39 months for patients treated at month 36) at ≤40 scheduled visits. Patients who met retreatment eligibility criteria could be retreated no more often than every 6 months.

MAIN OUTCOME MEASURES:

The predefined primary efficacy endpoint for the United States Food and Drug Administration was achievement of ≥15-letter improvement in BCVA from baseline at study end. Safety measures included adverse events and intraocular pressure (IOP).

RESULTS:

Mean number of treatments received over 3 years was 4.1, 4.4, and 3.3 with DEX implant 0.7 mg, DEX implant 0.35 mg, and sham, respectively. The percentage of patients with ≥15-letter improvement in BCVA from baseline at study end was greater with DEX implant 0.7 mg (22.2%) and DEX implant 0.35 mg (18.4%) than sham (12.0%; P ≤ 0.018). Mean average reduction in CRT from baseline was greater with DEX implant 0.7 mg (-111.6 μm) and DEX implant 0.35 mg (-107.9 μm) than sham (-41.9 μm; P < 0.001). Rates of cataract-related adverse events in phakic eyes were 67.9%, 64.1%, and 20.4% in the DEX implant 0.7 mg, DEX implant 0.35 mg, and sham groups, respectively. Increases in IOP were usually controlled with medication or no therapy; only 2 patients (0.6%) in the DEX implant 0.7 mg group and 1 (0.3%) in the DEX implant 0.35 mg group required trabeculectomy.

CONCLUSIONS:

The DEX implant 0.7 mg and 0.35 mg met the primary efficacy endpoint for improvement in BCVA. The safety profile was acceptable and consistent with previous reports.

PMID:
24907062
DOI:
10.1016/j.ophtha.2014.04.024
[Indexed for MEDLINE]
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