TY - JOUR
T1 - Periocular Triamcinolone vs. Intravitreal Triamcinolone vs. Intravitreal Dexamethasone Implant for the Treatment of Uveitic Macular Edema
T2 - The PeriOcular vs. INTravitreal corticosteroids for uveitic macular edema (POINT) Trial
AU - Multicenter Uveitis Steroid Treatment Trial Research Group
AU - Thorne, Jennifer E.
AU - Sugar, Elizabeth A.
AU - Holbrook, Janet T.
AU - Burke, Alyce E.
AU - Altaweel, Michael M.
AU - Vitale, Albert T.
AU - Acharya, Nisha R.
AU - Kempen, John H.
AU - Jabs, Douglas A.
N1 - Funding Information:
This study is a multicenter clinic trial supported by collaborative agreements from the National Eye Institute, National Institutes of Health (D.A.J.: U10EY024526, J.T.H.: U10EY024527, M.M.A.: U10EY024531). Allergan (Irvine, CA) donated a limited supply of dexamethasone implants for participants who could not obtain them otherwise. A representative of the National Eye Institute participated in the oversight of the study and review of the manuscript but not directly in the study design, data collection, analysis, and interpretation of the data, or in the preparation of this manuscript.
Publisher Copyright:
© 2018 American Academy of Ophthalmology
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
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U2 - 10.1016/j.ophtha.2018.08.021
DO - 10.1016/j.ophtha.2018.08.021
M3 - Article
C2 - 30269924
AN - SCOPUS:85060349677
SN - 0161-6420
VL - 126
SP - 283
EP - 295
JO - Ophthalmology
JF - Ophthalmology
IS - 2
ER -