0
We're unable to sign you in at this time. Please try again in a few minutes.
Retry
We were able to sign you in, but your subscription(s) could not be found. Please try again in a few minutes.
Retry
There may be a problem with your account. Please contact the AMA Service Center to resolve this issue.
Contact the AMA Service Center:
Telephone: 1 (800) 262-2350 or 1 (312) 670-7827  *   Email: subscriptions@jamanetwork.com
Error Message ......
Clinical Trials |

Dexamethasone Intravitreal Implant for Noninfectious Intermediate or Posterior Uveitis

Careen Lowder, MD, PhD; Rubens Belfort Jr, MD; Sue Lightman, MD; C. Stephen Foster, MD; Michael R. Robinson, MD; Rhett M. Schiffman, MD, MS, MHSA; Xiao-Yan Li, MD; Harry Cui, PhD; Scott M. Whitcup, MD ; Ozurdex HURON Study Group
Arch Ophthalmol. 2011;129(5):545-553. doi:10.1001/archophthalmol.2010.339.
Text Size: A A A
Published online

Extract

ObjectiveTo evaluate the safety and efficacy of 2 doses of dexamethasone intravitreal implant (DEX implant) for treatment of noninfectious intermediate or posterior uveitis.MethodsIn this 26-week trial, eyes with noninfectious intermediate or posterior uveitis were randomized to a single treatment with a 0.7-mg DEX implant (n = 77), 0.35-mg DEX implant (n = 76), or sham procedure (n = 76).Main Outcome MeasureThe main outcome measure was the proportion of eyes with a vitreous haze score of 0 at week 8.ResultsThe proportion of eyes with a vitreous haze score of 0 at week 8 was 47% with the 0.7-mg DEX implant, 36% with the 0.35-mg DEX implant, and 12% with the sham (P < .001); this benefit persisted through week 26. A gain of 15 or more letters from baseline best-corrected visual acuity was seen in significantly more eyes in the DEX implant groups than the sham group at all study visits. The percentage of eyes with intraocular pressure of 25 mm Hg or more peaked at 7.1% for the 0.7-mg DEX implant, 8.7% for the 0.35-mg DEX implant, and 4.2% for the sham (P > .05 at any visit). The incidence of cataract reported in the phakic eyes was 9 of 62 (15%) with the 0.7-mg DEX implant, 6 of 51 (12%) with the 0.35-mg DEX implant, and 4 of 55 (7%) with the sham (P > .05).ConclusionsIn patients with noninfectious intermediate or posterior uveitis, a single DEX implant significantly improved intraocular inflammation and visual acuity persisting for 6 months.Application to Clinical PracticeDexamethasone intravitreal implant may be used safely and effectively for treatment of intermediate and posterior uveitis.Trial Registrationclinicaltrials.gov Identifier: NCT00333814

Figures in this Article

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

First Page Preview

View Large
First page PDF preview

Figures

Place holder to copy figure label and caption
Figure 1.

Dexamethasone intravitreal implant. A, Placement of the dexamethasone intravitreal implant in the vitreous. B, Degradation of the implant over time: at administration (left) and after 3 weeks (right).

Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.

Flowchart of patient disposition. DEX implant indicates dexamethasone intravitreal implant.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 3.

Eyes with a vitreous haze score of 0. A, All eyes. B, Eyes with a baseline vitreous haze score of +1.5 or +2. C, Eyes with a baseline vitreous haze score of +3 or +4. When significant, P values are shown for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs sham. *One patient in the 0.7-mg DEX implant group with a baseline vitreous haze score of +1 was excluded from the analysis.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 4.

Eyes with at least 2 units of improvement in vitreous haze score. When significant, P values are shown for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs sham. The differences between the 0.35-mg DEX implant group and the sham group were statistically significant at week 3 (P = .034) and weeks 6 to 26 (P ≤ .003).

Graphic Jump Location
Place holder to copy figure label and caption
Figure 5.

Best-corrected visual acuity (BCVA). A, Eyes achieving a 15-letter or more improvement from baseline BCVA. B, Change from baseline BCVA. P > .05 for the 0.7-mg vs 0.35-mg dexamethasone intravitreal implant (DEX implant). P values are in comparison with the sham procedure.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 6.

Cumulative percentage of eyes requiring rescue medication in the study eye at each visit. P values are for the 0.7-mg dexamethasone intravitreal implant (DEX implant) vs the sham procedure.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 7.

Percentage of eyes with notable changes in intraocular pressure (IOP). A, Percentage of eyes with IOP of at least 35 mm Hg. B, Percentage of eyes with IOP of at least 25 mm Hg. DEX implant indicates dexamethasone intravitreal implant.

Graphic Jump Location
Place holder to copy figure label and caption
Figure 8.

Intraocular pressure (IOP)–lowering medication use in the 0.7-mg dexamethasone intravitreal implant (DEX implant) group only.

Graphic Jump Location

Tables

References

Correspondence

CME
Also Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
Please click the checkbox indicating that you have read the full article in order to submit your answers.
Your answers have been saved for later.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.

Multimedia

Some tools below are only available to our subscribers or users with an online account.

1,861 Views
155 Citations
×

Sign in

Purchase Options

• Buy this article
• Subscribe to the journal
• Rent this article ?

Related Content

Customize your page view by dragging & repositioning the boxes below.

Articles Related By Topic
Related Collections
PubMed Articles
Jobs
brightcove.createExperiences();