Dexamethasone Implant Improved Uveitis : Close to half of eyes that were treated with the 0.7-mg implant had a vitreous haze score of 0.

Major Finding: A single dexamethasone intravitreal implant significantly improved intraocular inflammation and visual acuity in patients with noninfectious intermediate or posterior uveitis.

Data Source: A 26-week, prospective, multicenter, masked, randomized, parallel-group, sham-controlled clinical trial of 229 patients with noninfectious intermediate or posterior uveitis.

Disclosures: This study was sponsored by Allergan, which participated in the design of the study, analysis of the data, and interpretation. Allergan also supervised the preparation of the manuscript and approved the final version. Five authors of the study are employees of Allergan.

A single dose of an intravitreal dexamethasone implant produced significant improvements in intraocular inflammation and visual acuity that lasted 6 months in patients with noninfectious intermediate or posterior uveitis, according to research published online.

The dexamethasone (DEX) implant, Ozurdex (Allergan Inc.), currently is approved for treatment of macular edema associated with retinal vein occlusions. Dr. Careen Lowder of the Cole Eye Institute, Cleveland, and her colleagues in the Ozurdex HURON Study Group sought to determine the safety of the DEX implant in the treatment of noninfectious intermediate and posterior uveitis.

She and her colleagues conducted a 26-week, prospective, multicenter, masked, parallel-group, sham-controlled clinical trial, in which they randomized 229 patients with a diagnosis of noninfectious intermediate or posterior uveitis to receive a sham procedure or treatment with a 0.7-mg or 0.35-mg DEX implant (Arch. Ophthalmol. 2011 Jan. 10 [doi:10.1001/archophthalmol.2010.339]).

The mean age of the patients was 45 years, more than 60% were women, and more than 60% were white. Of the 229 patients, 217 (95%) completed the 26-week study, 2 in the 0.7-mg group dropped out because of adverse events, and 1 in the 0.35-mg group discontinued because of a lack of efficacy.

The primary outcome measure was the vitreous haze score at 8 weeks, as measured by a standardized photographic scale ranging from 0 (no inflammation) to 4 (optic nerve head not visible).

Patients in all groups had a mean vitreous haze score of +2 (moderate blurring of the optic nerve head) at baseline.

At the 8-week follow-up, a vitreous haze score of 0 was observed in 47% of eyes with the 0.7-mg implant, 36% of those with the 0.35-mg implant, and 12% of those that had the sham procedure, the investigators said.

There was no significant difference between the two treatment doses, and the benefit associated with the implant persisted through the 26-week study.

In addition, one or more cells were present in the anterior chamber in 14.5% of the 0.7-mg group and 20.3% of the 0.35-mg group, compared with 38.7% of the sham group. And, two to six times as many eyes in the DEX implant groups vs. the sham group gained 15 or more letters of best-corrected visual acuity, a significant difference.

“The results of the present study demonstrate that the DEX implant has a favorable safety profile and can effectively reduce inflammation and substantially improve vision in eyes with noninfectious intermediate or posterior uveitis,” the researchers stated.

The findings suggest that the DEX implant may be used to safely and effectively treat intermediate and posterior uveitis. “Typically, the most common adverse events associated with intravitreal corticosteroids, which may have impacted use in the past, include increases in intraocular pressure and cataract,” the researchers wrote. “On any given follow-up visit in the present study, substantial increases in intraocular pressure (to 25 mm Hg or greater) occurred in less than 10% of treated eyes.”

One limitation in the study, however, was that patients were treated with a single DEX implant and followed for only 6 months. This limits the ability to assess the risk of cataract. “Future studies will be needed to explore the long-term effects of repeated treatment with the DEX implant in patients with uveitis and to evaluate the potential of this therapy in other retinal disorders beyond retinal vein occlusion,” the researchers wrote.

Major Finding: A single dexamethasone intravitreal implant significantly improved intraocular inflammation and visual acuity in patients with noninfectious intermediate or posterior uveitis.

Data Source: A 26-week, prospective, multicenter, masked, randomized, parallel-group, sham-controlled clinical trial of 229 patients with noninfectious intermediate or posterior uveitis.

Disclosures: This study was sponsored by Allergan, which participated in the design of the study, analysis of the data, and interpretation. Allergan also supervised the preparation of the manuscript and approved the final version. Five authors of the study are employees of Allergan.

A single dose of an intravitreal dexamethasone implant produced significant improvements in intraocular inflammation and visual acuity that lasted 6 months in patients with noninfectious intermediate or posterior uveitis, according to research published online.

The dexamethasone (DEX) implant, Ozurdex (Allergan Inc.), currently is approved for treatment of macular edema associated with retinal vein occlusions. Dr. Careen Lowder of the Cole Eye Institute, Cleveland, and her colleagues in the Ozurdex HURON Study Group sought to determine the safety of the DEX implant in the treatment of noninfectious intermediate and posterior uveitis.

She and her colleagues conducted a 26-week, prospective, multicenter, masked, parallel-group, sham-controlled clinical trial, in which they randomized 229 patients with a diagnosis of noninfectious intermediate or posterior uveitis to receive a sham procedure or treatment with a 0.7-mg or 0.35-mg DEX implant (Arch. Ophthalmol. 2011 Jan. 10 [doi:10.1001/archophthalmol.2010.339]).

The mean age of the patients was 45 years, more than 60% were women, and more than 60% were white. Of the 229 patients, 217 (95%) completed the 26-week study, 2 in the 0.7-mg group dropped out because of adverse events, and 1 in the 0.35-mg group discontinued because of a lack of efficacy.

The primary outcome measure was the vitreous haze score at 8 weeks, as measured by a standardized photographic scale ranging from 0 (no inflammation) to 4 (optic nerve head not visible).

Patients in all groups had a mean vitreous haze score of +2 (moderate blurring of the optic nerve head) at baseline.

At the 8-week follow-up, a vitreous haze score of 0 was observed in 47% of eyes with the 0.7-mg implant, 36% of those with the 0.35-mg implant, and 12% of those that had the sham procedure, the investigators said.

There was no significant difference between the two treatment doses, and the benefit associated with the implant persisted through the 26-week study.

In addition, one or more cells were present in the anterior chamber in 14.5% of the 0.7-mg group and 20.3% of the 0.35-mg group, compared with 38.7% of the sham group. And, two to six times as many eyes in the DEX implant groups vs. the sham group gained 15 or more letters of best-corrected visual acuity, a significant difference.

“The results of the present study demonstrate that the DEX implant has a favorable safety profile and can effectively reduce inflammation and substantially improve vision in eyes with noninfectious intermediate or posterior uveitis,” the researchers stated.

The findings suggest that the DEX implant may be used to safely and effectively treat intermediate and posterior uveitis. “Typically, the most common adverse events associated with intravitreal corticosteroids, which may have impacted use in the past, include increases in intraocular pressure and cataract,” the researchers wrote. “On any given follow-up visit in the present study, substantial increases in intraocular pressure (to 25 mm Hg or greater) occurred in less than 10% of treated eyes.”

One limitation in the study, however, was that patients were treated with a single DEX implant and followed for only 6 months. This limits the ability to assess the risk of cataract. “Future studies will be needed to explore the long-term effects of repeated treatment with the DEX implant in patients with uveitis and to evaluate the potential of this therapy in other retinal disorders beyond retinal vein occlusion,” the researchers wrote.

Major Finding: A single dexamethasone intravitreal implant significantly improved intraocular inflammation and visual acuity in patients with noninfectious intermediate or posterior uveitis.

Data Source: A 26-week, prospective, multicenter, masked, randomized, parallel-group, sham-controlled clinical trial of 229 patients with noninfectious intermediate or posterior uveitis.

Disclosures: This study was sponsored by Allergan, which participated in the design of the study, analysis of the data, and interpretation. Allergan also supervised the preparation of the manuscript and approved the final version. Five authors of the study are employees of Allergan.

A single dose of an intravitreal dexamethasone implant produced significant improvements in intraocular inflammation and visual acuity that lasted 6 months in patients with noninfectious intermediate or posterior uveitis, according to research published online.

The dexamethasone (DEX) implant, Ozurdex (Allergan Inc.), currently is approved for treatment of macular edema associated with retinal vein occlusions. Dr. Careen Lowder of the Cole Eye Institute, Cleveland, and her colleagues in the Ozurdex HURON Study Group sought to determine the safety of the DEX implant in the treatment of noninfectious intermediate and posterior uveitis.

She and her colleagues conducted a 26-week, prospective, multicenter, masked, parallel-group, sham-controlled clinical trial, in which they randomized 229 patients with a diagnosis of noninfectious intermediate or posterior uveitis to receive a sham procedure or treatment with a 0.7-mg or 0.35-mg DEX implant (Arch. Ophthalmol. 2011 Jan. 10 [doi:10.1001/archophthalmol.2010.339]).

The mean age of the patients was 45 years, more than 60% were women, and more than 60% were white. Of the 229 patients, 217 (95%) completed the 26-week study, 2 in the 0.7-mg group dropped out because of adverse events, and 1 in the 0.35-mg group discontinued because of a lack of efficacy.

The primary outcome measure was the vitreous haze score at 8 weeks, as measured by a standardized photographic scale ranging from 0 (no inflammation) to 4 (optic nerve head not visible).

Patients in all groups had a mean vitreous haze score of +2 (moderate blurring of the optic nerve head) at baseline.

At the 8-week follow-up, a vitreous haze score of 0 was observed in 47% of eyes with the 0.7-mg implant, 36% of those with the 0.35-mg implant, and 12% of those that had the sham procedure, the investigators said.

There was no significant difference between the two treatment doses, and the benefit associated with the implant persisted through the 26-week study.

In addition, one or more cells were present in the anterior chamber in 14.5% of the 0.7-mg group and 20.3% of the 0.35-mg group, compared with 38.7% of the sham group. And, two to six times as many eyes in the DEX implant groups vs. the sham group gained 15 or more letters of best-corrected visual acuity, a significant difference.

“The results of the present study demonstrate that the DEX implant has a favorable safety profile and can effectively reduce inflammation and substantially improve vision in eyes with noninfectious intermediate or posterior uveitis,” the researchers stated.

The findings suggest that the DEX implant may be used to safely and effectively treat intermediate and posterior uveitis. “Typically, the most common adverse events associated with intravitreal corticosteroids, which may have impacted use in the past, include increases in intraocular pressure and cataract,” the researchers wrote. “On any given follow-up visit in the present study, substantial increases in intraocular pressure (to 25 mm Hg or greater) occurred in less than 10% of treated eyes.”

One limitation in the study, however, was that patients were treated with a single DEX implant and followed for only 6 months. This limits the ability to assess the risk of cataract. “Future studies will be needed to explore the long-term effects of repeated treatment with the DEX implant in patients with uveitis and to evaluate the potential of this therapy in other retinal disorders beyond retinal vein occlusion,” the researchers wrote.