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 ¼ 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of 300 mm by optical coherence tomography. Methods: Patientswere randomized in a 1:1:1 ratio to study treatmentwithDEX implant 0.7mg,DEX implant 0.35 mg, or shamprocedure andfollowedfor 3 years (or 39months for patients treatedatmonth36) at40 scheduledvisits. 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 mm) and DEX implant 0.35 mg (107.9 mm) than sham (41.9 mm; 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. Ophthalmology 2014;121:1904- 1914 ª 2014 by the American Academy of Ophthalmology
Three-year randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema / David S., Boyer; Md, ; 1 Young Hee, Yoon; Md, Phd; 2 Rubens, Belfort; Jr, Md; Phd, ; 3 Francesco, Bandello; Md, ; 4 Raj K., Maturi; Md, ; 5 Albert J., Augustin; Md, ; 6 Xiao Yan, Li; Md, ; 7 Harry, Cui; Ms, ; 7 Yehia, Hashad; Md, ; 7 Scott M., Whitcup; MDThe MEAD Study Group Principal Investigators: Suel, Abujamra; James, Acton; Fareed, Ali; Andrew, Antoszyk; Albert J., Augustin; Carl C., Awh; Adiel, Barak; Karl Ulrich Bartz, Schmidt; Caroline R., Baumal; Rubens, Belfort; J., R.; Muna, Bhende; David S., Boyer; William Z., Bridges; J., R.; David M., Brown; Trevor, Carmichael; Ken, Carnevale; Antonio M., Casella; Tom, Chang; Daniel, Chechik; San Ni, Chen; Lawrence P., Chong; Victor, Chong; Joel, Corwin; Catherine Creuzot, Garcher; Alan, Cruess; Mark, Daniell; Marcos P., de Avila; Haroldo Vieira de, Moraes; J., R.; Robert G., Devenyi; Bernard H., Doft; Mark, Donaldson; Richard, Dreyer; Dean, Eliott; Harry M., Engel; Jan, Ernest; Thomas F., Essman; Philip M., Falcone; Sharon, Fekrat; Joseph R., Ferencz; Joao L., Ferreira; Joao, Figueira; Ivan, Fiser; Bradley, Foster; Gregory M., Fox; William R., Freeman; S. P., Garg; Mark, Gillies; David, Glaser; Burton G., Goldstein; Andre M. V., Gomes; John R., Gonder; Lingam, Gopal; Petrus, Gous; Amod, Gupta; Anurag, Gupta; Lawrence, Halperin; Dennis, Han; Seenu M., Hariprasad; Frank G., Holz; Peter, Kaiser; Bohdana, Kalvodova; Barrett, Katz; Randy S., Katz; Dariusz, Kecik; Judianne, Kellaway; Itamar, Klemperer; Baruch, Kuppermann; Paolo, Lanzetta; Rosangela, Lattanzio; Won Ki, Lee; John, Lehr; Monique, Leys; Isaac, Loose; Andrew, Lotery; Da Wen, Lu; Paul, Mccartney; Ajit B., Majji; Jose A., Martinez; Pascale, Massin; Raj K., Maturi; Ugo, Menchini; Geeta, Menon; Mark, Michels; Edoardo, Midena; James, Miller; J., R.; Paul, Mitchell; Joseph, Moisseiev; Lawrence, Morse; Rafael, Navarro; Janos, Nemeth; Henry, Newland; Richard, Newsom; John, Nichols; Juan, Orellana; Nicola, Orzalesi; Augusto, Paranhos; J., R.; Robert, Park; Susanna, Park; Maurizio Battaglia, Parodi; Peter R., Pavan; James, Peace; Don J., Perez Ortiz; Ayala, Pollack; Kim, Ramaswamy; Ramakrishna, Ratnakaram; Giuseppe, Ravalico; Jiri, Rehak; Kourous, Rezaei; Stanislao, Rizzo; Francisco J., Rodriguez Alvira; Jean Paul, Romanet; Steven, Rose; Richard B., Rosen; Luca, Rossetti; Jose Maria Ruiz, Moreno; Srinivas, Sadda; Kenneth, Sall; Dirk, Sandner; Alvaro Fernandez Vega, Sanz; Gil, Sartani; Stefanie, Schmickler; Steven D., Schwartz; Y. R., Sharma; Shwu Jiuan, Sheu; Michael, Singer; Sobha, Sivaprasad; Gisele, Soubrane; Petr, Soucek; Eric H., Souied; Giovanni, Staurenghi; Jan, Studnicka; Marta Suarez, Figueroa; Walter Y., Takahashi; Tognetto, Daniele; Patrick L., Tsai; Lawrence J., Ulanski; Ii, ; Harvey, Uy; Monica, Varano; Miroslav, Veith; Igor, Vicha; Francesco, Viola; Linda, Visser; Dov, Weinberger; Glenn L., Wing; Edmund, Wong; Tien, Wong; Edward, Wylegala; Jiong, Yan; Young Hee, Yoon; Lucy H., Young; Hyeong G., Yu; Ingrid E., Zimmer Galler. - In: OPHTHALMOLOGY. - ISSN 0161-6420. - ELETTRONICO. - 121:10(2014), pp. 1904-1914. [10.1016/j.ophtha.2014.04.024]
Three-year randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with diabetic macular edema.
TOGNETTO, DANIELE;
2014-01-01
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 ¼ 1048) with DME, best-corrected visual acuity (BCVA) of 20/50 to 20/200 Snellen equivalent, and central retinal thickness (CRT) of 300 mm by optical coherence tomography. Methods: Patientswere randomized in a 1:1:1 ratio to study treatmentwithDEX implant 0.7mg,DEX implant 0.35 mg, or shamprocedure andfollowedfor 3 years (or 39months for patients treatedatmonth36) at40 scheduledvisits. 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 mm) and DEX implant 0.35 mg (107.9 mm) than sham (41.9 mm; 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. Ophthalmology 2014;121:1904- 1914 ª 2014 by the American Academy of OphthalmologyPubblicazioni consigliate
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