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Use of the Fluocinolone Acetonide Intravitreal Implant for the Treatment of Noninfectious Posterior Uveitis: 3-Year Results of a Randomized Clinical Trial in a Predominantly Asian Population.

Sangwan VS, Pearson PA, Paul H, Comstock TL - Ophthalmol Ther (2014)

Bottom Line: Outcomes included uveitis recurrence rate, best-corrected visual acuity (BCVA), use of adjunctive therapy, and safety.Recurrence rates for implanted eyes decreased from 42.3% during the 1-year pre-implantation period to 25.9% during the 3-year post-implantation period (P = 0.0003) and increased for nonimplanted fellow eyes from 19.8 to 59.7% (P < 0.0001).More implanted eyes gained ≥3 lines of BCVA compared to nonimplanted fellow eyes (P ≤ 0.0046); and implanted eyes required less adjunctive systemic therapy and fewer periocular injections (P < 0.0001).

View Article: PubMed Central - PubMed

Affiliation: L. V. Prasad Eye Institute, Hyderabad, India, vsangwan@lvpei.org.

ABSTRACT

Introduction: The fluocinolone acetonide (FA) intravitreal implant 0.59 mg (Retisert(®), Bausch + Lomb, Rochester, NY, USA) provides sustained release of FA directly to the vitreous cavity over a prolonged period of time. The purpose of this study was to evaluate the safety and efficacy of a 0.59- and 2.1-mg FA intravitreal implant in patients with noninfectious posterior uveitis.

Methods: A prospective, multicenter, randomized, double-masked, dose-controlled study was performed. Patients were randomized to the 0.59- or 2.1-mg FA implant surgically placed in the vitreous cavity through a pars plana incision and were evaluated at visits through 3 years. Patients with bilateral disease had the more severely affected eye implanted. Outcomes included uveitis recurrence rate, best-corrected visual acuity (BCVA), use of adjunctive therapy, and safety.

Results: A total of 239 patients, predominantly Asian, were implanted (n = 117, 0.59-mg implant; n = 122, 2.1-mg implant). Approximately 80% of patients had bilateral disease. Recurrence rates for implanted eyes decreased from 42.3% during the 1-year pre-implantation period to 25.9% during the 3-year post-implantation period (P = 0.0003) and increased for nonimplanted fellow eyes from 19.8 to 59.7% (P < 0.0001). More implanted eyes gained ≥3 lines of BCVA compared to nonimplanted fellow eyes (P ≤ 0.0046); and implanted eyes required less adjunctive systemic therapy and fewer periocular injections (P < 0.0001). Elevations of intraocular pressure (≥10 mm Hg) were frequent in implanted eyes (67.8%, 0.59-mg implant; 71.3%, 2.1-mg implant); nearly all (94.9%) phakic implanted eyes required cataract surgery.

Conclusion: The FA intravitreal implant significantly reduced uveitis recurrence rates and led to improvements in visual acuity and reductions in adjunctive therapy. Lens clarity and intraocular pressure require monitoring.

No MeSH data available.


Related in: MedlinePlus

Proportion of eyes with an improvement (left panel) or deterioration (right panel) in visual acuity from baseline of at least 0.30 logMAR at 3 years in the 0.59- and 2.1-mg implant groups. (P values for the within-treatment comparison of study eye versus fellow eye). *P < 0.0001. †P = 0.0046. logMAR logarithm of the minimum angle resolution
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Fig3: Proportion of eyes with an improvement (left panel) or deterioration (right panel) in visual acuity from baseline of at least 0.30 logMAR at 3 years in the 0.59- and 2.1-mg implant groups. (P values for the within-treatment comparison of study eye versus fellow eye). *P < 0.0001. †P = 0.0046. logMAR logarithm of the minimum angle resolution

Mentions: In the 0.59-mg group, 2.1-mg group, and combined dose group at the 3-year visit, 31.1% (33/106), 23.6% (25/106), and 27.4% (58/212) of implanted eyes, respectively, improved by ≥3 lines over baseline compared to 7.6% (8/105), 11.4% (12/105), and 9.5% (20/210) of nonimplanted eyes (P ≤ 0.0046 for the difference in each dose group). In contrast, there was no significant difference between implanted eyes (both doses) and fellow nonimplanted eyes in the proportion of eyes that lost ≥3 lines of BCVA from baseline at the 3-year visit (Fig. 3). Most instances of ≥3 line loss in BCVA of implanted eyes occurred during the immediate postoperative period. Loss of ≥3 lines in BCVA was also often observed between 12 and 21 months post-implantation when cataracts were most prevalent. At the 3-year follow-up visit, 9.4% (10/116) of implanted eyes in the 0.59-mg FA implant group had a loss of ≥3 lines of BCVA compared to 17.0% (18/106) of implanted eyes in the 2.1-mg implant group.Fig. 3


Use of the Fluocinolone Acetonide Intravitreal Implant for the Treatment of Noninfectious Posterior Uveitis: 3-Year Results of a Randomized Clinical Trial in a Predominantly Asian Population.

Sangwan VS, Pearson PA, Paul H, Comstock TL - Ophthalmol Ther (2014)

Proportion of eyes with an improvement (left panel) or deterioration (right panel) in visual acuity from baseline of at least 0.30 logMAR at 3 years in the 0.59- and 2.1-mg implant groups. (P values for the within-treatment comparison of study eye versus fellow eye). *P < 0.0001. †P = 0.0046. logMAR logarithm of the minimum angle resolution
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4470982&req=5

Fig3: Proportion of eyes with an improvement (left panel) or deterioration (right panel) in visual acuity from baseline of at least 0.30 logMAR at 3 years in the 0.59- and 2.1-mg implant groups. (P values for the within-treatment comparison of study eye versus fellow eye). *P < 0.0001. †P = 0.0046. logMAR logarithm of the minimum angle resolution
Mentions: In the 0.59-mg group, 2.1-mg group, and combined dose group at the 3-year visit, 31.1% (33/106), 23.6% (25/106), and 27.4% (58/212) of implanted eyes, respectively, improved by ≥3 lines over baseline compared to 7.6% (8/105), 11.4% (12/105), and 9.5% (20/210) of nonimplanted eyes (P ≤ 0.0046 for the difference in each dose group). In contrast, there was no significant difference between implanted eyes (both doses) and fellow nonimplanted eyes in the proportion of eyes that lost ≥3 lines of BCVA from baseline at the 3-year visit (Fig. 3). Most instances of ≥3 line loss in BCVA of implanted eyes occurred during the immediate postoperative period. Loss of ≥3 lines in BCVA was also often observed between 12 and 21 months post-implantation when cataracts were most prevalent. At the 3-year follow-up visit, 9.4% (10/116) of implanted eyes in the 0.59-mg FA implant group had a loss of ≥3 lines of BCVA compared to 17.0% (18/106) of implanted eyes in the 2.1-mg implant group.Fig. 3

Bottom Line: Outcomes included uveitis recurrence rate, best-corrected visual acuity (BCVA), use of adjunctive therapy, and safety.Recurrence rates for implanted eyes decreased from 42.3% during the 1-year pre-implantation period to 25.9% during the 3-year post-implantation period (P = 0.0003) and increased for nonimplanted fellow eyes from 19.8 to 59.7% (P < 0.0001).More implanted eyes gained ≥3 lines of BCVA compared to nonimplanted fellow eyes (P ≤ 0.0046); and implanted eyes required less adjunctive systemic therapy and fewer periocular injections (P < 0.0001).

View Article: PubMed Central - PubMed

Affiliation: L. V. Prasad Eye Institute, Hyderabad, India, vsangwan@lvpei.org.

ABSTRACT

Introduction: The fluocinolone acetonide (FA) intravitreal implant 0.59 mg (Retisert(®), Bausch + Lomb, Rochester, NY, USA) provides sustained release of FA directly to the vitreous cavity over a prolonged period of time. The purpose of this study was to evaluate the safety and efficacy of a 0.59- and 2.1-mg FA intravitreal implant in patients with noninfectious posterior uveitis.

Methods: A prospective, multicenter, randomized, double-masked, dose-controlled study was performed. Patients were randomized to the 0.59- or 2.1-mg FA implant surgically placed in the vitreous cavity through a pars plana incision and were evaluated at visits through 3 years. Patients with bilateral disease had the more severely affected eye implanted. Outcomes included uveitis recurrence rate, best-corrected visual acuity (BCVA), use of adjunctive therapy, and safety.

Results: A total of 239 patients, predominantly Asian, were implanted (n = 117, 0.59-mg implant; n = 122, 2.1-mg implant). Approximately 80% of patients had bilateral disease. Recurrence rates for implanted eyes decreased from 42.3% during the 1-year pre-implantation period to 25.9% during the 3-year post-implantation period (P = 0.0003) and increased for nonimplanted fellow eyes from 19.8 to 59.7% (P < 0.0001). More implanted eyes gained ≥3 lines of BCVA compared to nonimplanted fellow eyes (P ≤ 0.0046); and implanted eyes required less adjunctive systemic therapy and fewer periocular injections (P < 0.0001). Elevations of intraocular pressure (≥10 mm Hg) were frequent in implanted eyes (67.8%, 0.59-mg implant; 71.3%, 2.1-mg implant); nearly all (94.9%) phakic implanted eyes required cataract surgery.

Conclusion: The FA intravitreal implant significantly reduced uveitis recurrence rates and led to improvements in visual acuity and reductions in adjunctive therapy. Lens clarity and intraocular pressure require monitoring.

No MeSH data available.


Related in: MedlinePlus