PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (POINT)
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|ClinicalTrials.gov Identifier: NCT02374060|
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : June 1, 2018
To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects.
Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.
|Condition or disease||Intervention/treatment||Phase|
|Macular Edema Uveitis||Drug: Periocular triamcinolone 40 mg Drug: Intravitreal triamcinolone 4 mg Drug: Dexamethasone intravitreal implant||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial|
|Actual Study Start Date :||June 16, 2015|
|Actual Primary Completion Date :||August 30, 2017|
|Actual Study Completion Date :||January 4, 2018|
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
- 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.
- IOP elevation of >=24 mm Hg [ Time Frame: During 24 weeks of follow-up ]Rate of IOP elevation of >=24 mm Hg during follow-up
- IOP elevation of >=30 mm Hg [ Time Frame: During 24 weeks of follow-up ]Rate of IOP elevation of >=30 mm Hg during follow-up
- IOP elevation of >=10 mm Hg from baseline [ Time Frame: During 24 weeks of follow-up ]Rate of IOP elevation of >=10 mm Hg from baseline
- Change in macular thickness as measured by OCT [ Time Frame: Over 24 weeks of follow-up ]Percent change in macular thickness as measured by OCT
- >= 20% reduction in macular thickness (or normalization even if <20% reduction [ Time Frame: Over 24 weeks of follow-up ]Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction)
- Resolution of macular edema [ Time Frame: Over 24 weeks of follow-up ]Proportion of eyes with resolution of macular edema defined as normalization of the macular thickness to within plus or minus 2 standard deviations of the normative mean for the OCT machine used
- Change in best-corrected visual acuity [ Time Frame: Over 24 weeks of follow-up ]Mean change in best-corrected visual acuity
- Vitreous hemorrhage [ Time Frame: During 24 weeks of follow-up ]Count of vitreous hemorrhage as an immediate complication of injection
- Retinal tear/detachment [ Time Frame: During 24 weeks of follow-up ]Count of retinal tears/detachments
- Endopthalmitis [ Time Frame: During 24 weeks of folllow-ip ]Occurrence of endophalmitis
- Severe vision loss [ Time Frame: During 24 weeks of follow-up ]Severe vision loss (>= 15 standard letters)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374060
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|Study Chair:||Douglas A Jabs, MD, MBA||Icahn School of Medicine, Noutn Sinai, New York, NY|