PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)
|Macular Edema Uveitis||Drug: Periocular triamcinolone 40 mg Drug: Intravitreal triamcinolone 4 mg Drug: Dexamethasone intravitreal implant||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial|
- Percent change in central subfield thickness from the baseline OCT measurement [ Time Frame: At week 8 visit ]The primary outcome is the percent change in central subfield thickness from the baseline OCT measurement at the 8-week visit. The time point of 8 weeks was chosen for assessment of the primary outcome because it encompasses the window for maximum benefit for all three treatment strategies. The results will be transformed to represent relative change. Assessment of OCT outcomes will be performed by masked readers.
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Periocular triamcinolone 40mg
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 IF:
Drug: Periocular triamcinolone 40 mg
Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.
Other Name: Kenalog
Active Comparator: Intravitreal triamcinolone 4mg
(preservative-free preparation, Triescence at U.S. clinics; Triesence preferred at non-U.S. clinics but Kenalog allowed) (4 mg) Initial injection at Week 0
Second injection permitted at Week 8 IF:
Drug: Intravitreal triamcinolone 4 mg
Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.
Other Name: Triescence (in U.S); Kenalog allowed at non-U.S. clinics
Active Comparator: Dexamethasoneintravitreal implant
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 IF:
Drug: Dexamethasone intravitreal implant
• Standard preparation as described for intravitreal injections.
Other Name: Ozurdex
Macular edema is the most common structural complication and leading cause of visual loss in patients with uveitis. Regional injections of corticosteroids are the most frequently used treatments specifically for uveitic macular edema but there is a lack of high quality evidence to guide choice of drug (e.g., triamcinolone acetonide, dexamethasone) and route of administration (e.g. periocular, intravitreal). The question of how to approach regional treatment of uveitic macular edema is a key question for ophthalmologists treating these patients. The Periocular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial is a randomized trial designed to compare the relative efficacy of three regional corticosteroids commonly utilized for the initial regional treatment of uveitic macular edema, periocular triamcinolone (Kenalog® , Bristol-Myers Squibb Company, Princeton, NJ), intravitreal triamcinolone (Triesence™, Alcon Pharmaceuticals, Fort Worth, TX), and the intravitreal dexamethasone implant (Ozurdex®, Allergan, Irvine CA) will be conducted by the MUST Research Group clinical centers throughout the U.S. and one each in Australia and the UK. After signing informed consent and undergoing eligibility evaluation, eligible patients will be randomized to one of the three study treatments to be administered at the first study visit. Randomization is by participant, if both eyes meet eligibility requirements then both eyes receive assigned treatment. The design outcome is the percent change in central subfield macular thickness on OCT from baseline to the 8 week visit. After assessment of the primary outcome at 8 weeks, second injections and best medical judgment will be used if macular edema has not improved as follows:
Eye(s) meeting trial eligibility criteria receive initial injection of assigned treatment at P01 visit.
Second injection of assigned treatment permitted at 8 week visit for periocular triamcinolone and intravitreal triamcinolone and at 12 week visit for intravitreal dexamethasone if
- Eye does not meet the improvement definition (a 20% decrease in central subfield thickness of the macula) or
- Eye has a normal central subfield thickness but has cystoid spaces in the 1 mm central subfield or
- ME is worse after initial improvement
And the following repeat injection criterion are met:
• IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Eyes demonstrating no improvement or worsening of ME as measured by the central submacular thickness on OCT (at week 12 for periocular and intravitreal triamcinolone arms and at week 20 for intravitreal dexamethasone arm) are considered primary treatment non-responders.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02374060
Show 26 Study Locations
|Study Chair:||Douglas A Jabs, MD, MBA||Icahn School of Medicine, Noutn Sinai, New York, NY|