Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema: The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial

Abstract

Purpose: To evaluate the comparative effectiveness of 3 regional corticosteroid injections for uveitic macular edema (ME): periocular triamcinolone acetonide (PTA), intravitreal triamcinolone acetonide (ITA), and the intravitreal dexamethasone implant (IDI).

Design: Multicenter, randomized clinical trial.

Participants: Patients with uveitic ME.

Methods: Patients were randomized 1:1:1 to receive 1 of the 3 therapies. Patients with bilateral ME were assigned the same treatment for both eyes.

Main outcome measures: The primary outcome was the proportion of baseline (PropBL) central subfield thickness (CST) at 8 weeks (CST at 8 weeks/CST at baseline) assessed with OCT by masked readers. Secondary outcomes included ≥20% improvement and resolution of ME, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) events over 24 weeks.

Results: All treatment groups demonstrated improved CST during follow-up. At 8 weeks, each group had clinically meaningful reductions in CST relative to baseline (PropBL: 0.77, 0.61, and 0.54, respectively, which translates to reductions of 23%, 39%, and 46% for PTA, ITA, and IDI, respectively). Intravitreal triamcinolone acetonide (PropBL ITA/PropBL PTA, hazard ratio [HR], 0.79; 99.87% confidence interval [CI], 0.65-0.96) and IDI (PropBL IDI/PropBL PTA, HR, 0.69; 99.87% CI, 0.56-0.86) had larger reductions in CST than PTA (P < 0.0001). Intravitreal dexamethasone implant was noninferior to ITA at 8 weeks (PropBL IDI/PropBL ITA, HR, 0.88; 99.87% CI, 0.71-1.08). Both ITA and IDI treatments also were superior to PTA treatment in improving and resolving uveitic ME. All treatment groups demonstrated BCVA improvement throughout follow-up. Both ITA and IDI groups had improvements in BCVA that was 5 letters greater than in the PTA group at 8 weeks (P < 0.004). The risk of having IOP ≥24 mmHg was higher in the intravitreal treatment groups compared with the periocular group (HR, 1.83; 95% CI, 0.91-3.65 and HR, 2.52; 95% CI, 1.29-4.91 for ITA and IDI, respectively); however, there was no significant difference between the 2 intravitreal treatment groups.

Conclusions: Intravitreal triamcinolone acetonide and the IDI were superior to PTA for treating uveitic ME with modest increases in the risk of IOP elevation. This risk did not differ significantly between intravitreal treatments.

Trial registration: ClinicalTrials.gov NCT02374060.

Conflict of interest statement

Conflicts of Interest: Jennifer E. Thorne, MD, PhD, Grant support from Allergan, Inc., Consultant for AbbVie, Inc., Gilead, Santen; Janet T. Holbrook, PhD, Data Safety Monitoring Board member for Gilead; Albert T. Vitale, MD, Consultant for AbbVie, Inc., ACIONT; Nisha R. Acharya, MD, MBA, AbbVie Inc., Santen; John H. Kempen, MD, PhD, Consultant for Gilead, Santen; Elizabeth A. Sugar, PhD, Alyce Burke, MPH, Michael M. Altaweel, MD, and Douglas A. Jabs, MD, MBA, none.

Copyright © 2018 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1.

CONSORT diagram of the POINT trial.

Figure 2.

Change in retinal thickness at the central subfield measured by optical coherence tomography at each visit by treatment group.

Figure 3.

Retinal thickness at the central subfield measured by optical coherence tomography at each visit by treatment group.

Figure 4.

Proportion of eyes with improvement (a) and resolution (b) in macular edema at each visit for periocular triamcinolone (dashed line, circle), intravitreal triamcinolone (solid line, triangle) and dexamethasone implant (staggered line, square).

Figure 4.

Proportion of eyes with improvement (a) and resolution (b) in macular edema at each visit for periocular triamcinolone (dashed line, circle), intravitreal triamcinolone (solid line, triangle) and dexamethasone implant (staggered line, square).

Figure 5.

Best-corrected visual acuity at each visit by treatment group.

Figure 6.

Intraocular pressure (IOP) (a) and use of IOP medication (b) at each visit for periocular triamcinolone (dashed line, circle), intravitreal triamcinolone (solid line, triangle) and dexamethasone implant (staggered line, square).

Figure 6.

Intraocular pressure (IOP) (a) and use of IOP medication (b) at each visit for periocular triamcinolone (dashed line, circle), intravitreal triamcinolone (solid line, triangle) and dexamethasone implant (staggered line, square).