Trial Outcomes & Findings for PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial (NCT NCT02374060)
NCT ID: NCT02374060
Last Updated: 2018-12-04
Results Overview
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. 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. Retinal thickness was evaluated using masked assessments of OCT images.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
At baseline and 8 weeks
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Periocular Triamcinolone 40mg
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
|---|---|---|---|
|
Overall Study
STARTED
|
65
|
63
|
64
|
|
Overall Study
COMPLETED
|
63
|
62
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial
Baseline characteristics by cohort
| Measure |
Periocular Triamcinolone 40mg
n=74 Eyes with macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Intravitreal Triamcinolone 4mg
n=82 Eyes with macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Total
n=235 Eyes with macular edema
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
56 years
n=7 Participants
|
55 years
n=5 Participants
|
55 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
119 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
46 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
122 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Intraocular pressure
|
14 mm Hg
n=74 Eyes with macular edema
|
14 mm Hg
n=82 Eyes with macular edema
|
13 mm Hg
n=79 Eyes with macular edema
|
14 mm Hg
n=235 Eyes with macular edema
|
|
Visual acuity
|
68 Standard letters
n=74 Eyes with macular edema
|
63 Standard letters
n=82 Eyes with macular edema
|
64 Standard letters
n=79 Eyes with macular edema
|
64 Standard letters
n=235 Eyes with macular edema
|
|
Retinal thickness at the center subfield
|
438 um
n=74 Eyes with macular edema
|
485 um
n=82 Eyes with macular edema
|
449 um
n=79 Eyes with macular edema
|
462 um
n=235 Eyes with macular edema
|
|
Concomitant systemic medication
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and 8 weeksPopulation: All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized")
The primary outcome is the change in central subfield thickness from baseline to 8 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better. 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. Retinal thickness was evaluated using masked assessments of OCT images.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks
|
.61 proportion of baseline retinal thickness
Interval 0.53 to 0.7
|
.54 proportion of baseline retinal thickness
Interval 0.46 to 0.63
|
.77 proportion of baseline retinal thickness
Interval 0.67 to 0.89
|
SECONDARY outcome
Timeframe: At baseline and the 24 week visitPopulation: All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized")
The primary outcome is the change in central subfield thickness from baseline to 24 weeks measured on a relative scale as the the proportion of the baseline central subfield thickness. Values less than 1 indicate a decrease in retinal thickness with lower values indicating greater decreases. Smaller values are better.The time point of 24 weeks was chosen to evaluate the duration of response and the need for additional injections.Retinal thickness was evaluated using masked assessments of OCT images.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks
|
0.64 proportion of baseline retinal thickness
Interval 0.56 to 0.74
|
0.61 proportion of baseline retinal thickness
Interval 0.52 to 0.71
|
0.68 proportion of baseline retinal thickness
Interval 0.59 to 0.79
|
SECONDARY outcome
Timeframe: Over 8 weeks of follow-upProportion of eyes with \>=20% reduction in macular thickness (or normalization of macular thickness even if there is \<20% reduction) at 8 weeks.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks
|
0.79 Proportion of eyes
Interval 0.7 to 0.88
|
0.84 Proportion of eyes
Interval 0.74 to 0.94
|
0.41 Proportion of eyes
Interval 0.29 to 0.52
|
SECONDARY outcome
Timeframe: Over 24 weeks of follow-upProportion of eyes with \>=20% reduction in macular thickness (or normalization of macular thickness even if there is \<20% reduction) at 24 weeks
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks
|
0.73 Proportion of eyes
Interval 0.63 to 0.83
|
0.74 Proportion of eyes
Interval 0.61 to 0.85
|
0.61 Proportion of eyes
Interval 0.5 to 0.72
|
SECONDARY outcome
Timeframe: Over 8 weeks of follow-upProportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., \< 260 um on the standardized scale) at 8 weeks. The greater the proportion the more eyes achieved resolution of macular edema.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Eyes With Resolution of Macular Edema at 8 Weeks
|
0.47 Proportion of eyes
Interval 0.34 to 0.6
|
0.61 Proportion of eyes
Interval 0.48 to 0.73
|
0.20 Proportion of eyes
Interval 0.12 to 0.3
|
SECONDARY outcome
Timeframe: Over 24 weeks of follow-upProportion of eyes with resolution of macular edema defined as normalization of the macular thickness (i.e., \<260 um on the standard scale) at 24 weeks.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Proportion of Eyes With Resolution of Macular Edema at 24 Weeks
|
0.36 Proportion of eyes
Interval 0.24 to 0.48
|
0.41 Proportion of eyes
Interval 0.28 to 0.54
|
0.35 Proportion of eyes
Interval 0.24 to 0.47
|
SECONDARY outcome
Timeframe: Over 8 weeks of follow-upMean change in best-corrected visual acuity from baseline to 8 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Change in Best-corrected Visual Acuity at 8 Weeks
|
9.70 Standard letters
Interval 7.26 to 12.13
|
9.53 Standard letters
Interval 7.01 to 12.05
|
4.37 Standard letters
Interval 1.86 to 6.89
|
SECONDARY outcome
Timeframe: Over 24 weeks of follow-upMean change in best-corrected visual acuity from baseline to 24 weeks. Participants' visual acuity was measured by certified examiners with best refractive correction in place.Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Change in Best-corrected Visual Acuity at 24 Weeks
|
9.60 Standard letters
Interval 6.87 to 12.34
|
9.21 Standard letters
Interval 6.62 to 11.8
|
4.07 Standard letters
Interval 0.64 to 7.51
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upCount of eyes with vitreous hemorrhage as an immediate complication of injection.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Number of Eyes With Vitreous Hemorrhage
|
0 Eyes with uveitic macular edema
|
1 Eyes with uveitic macular edema
|
1 Eyes with uveitic macular edema
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upCount of eyes with retinal tears or detachments during the course of follow-up.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Number of Eyes With Retinal Tear or Detachment
|
0 Eyes with uveitic macular edema
|
0 Eyes with uveitic macular edema
|
1 Eyes with uveitic macular edema
|
SECONDARY outcome
Timeframe: During 24 weeks of folllow-ipCount of eyes with an occurrence of endophthalmitis
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=82 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=79 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Number of Eyes With Endophthalmitis
|
0 Eyes with uveitic macular edema
|
0 Eyes with uveitic macular edema
|
1 Eyes with uveitic macular edema
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upCumulative proportion of eyes with uveitic macular edema who experience severe vision loss (\>= 15 standard letters) during the 24 weeks of follow-up.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=81 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=78 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Cumulative Proportion of Eyes With Severe Vision Loss
|
0.10 Cumulative proportion of eyes at 24 wks
Interval 0.0 to 0.22
|
0.05 Cumulative proportion of eyes at 24 wks
Interval 0.0 to 0.1
|
0.11 Cumulative proportion of eyes at 24 wks
Interval 0.04 to 0.18
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upCumulative proportion of eyes with uveitic macular edema that experience an IOP elevation of \>=10 mm Hg higher than the baseline level during 24 weeks of follow-up.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=81 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=78 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline
|
0.26 Cumulative proportion of eyes at 24 wks
Interval 0.13 to 0.38
|
0.39 Cumulative proportion of eyes at 24 wks
Interval 0.2 to 0.53
|
0.14 Cumulative proportion of eyes at 24 wks
Interval 0.05 to 0.22
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upPopulation: As randomized
Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to \>=24 mm Hg during 24 weeks of follow-up.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=81 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=78 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg
|
0.30 Cumulative proportion of eyes at 24 wks
Interval 0.17 to 0.4
|
0.41 Cumulative proportion of eyes at 24 wks
Interval 0.26 to 0.53
|
0.20 Cumulative proportion of eyes at 24 wks
Interval 0.09 to 0.29
|
SECONDARY outcome
Timeframe: During 24 weeks of follow-upCumulative proportion of eyes with uveitic macular edema that experience elevated IOP to \>=30 mm Hg during 24 weeks of follow-up.
Outcome measures
| Measure |
Intravitreal Triamcinolone 4mg
n=81 Eyes with uveitis macular edema
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=78 Eyes with uveitis macular edema
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
Periocular Triamcinolone 40mg
n=74 Eyes with uveitis macular edema
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
|---|---|---|---|
|
Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg
|
0.06 Cumulative proportion of eyes at 24 wks
Interval 0.01 to 0.12
|
0.04 Cumulative proportion of eyes at 24 wks
Interval 0.0 to 0.08
|
0.06 Cumulative proportion of eyes at 24 wks
Interval 0.0 to 0.12
|
Adverse Events
Periocular Triamcinolone 40mg
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravitreal Triamcinolone 4mg
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexamethasoneintravitreal Implant
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Periocular Triamcinolone 40mg
n=65 participants at risk
Periocular triamcinolone acetonide (Kenalog), 40 mg Initial injection at Week 0
Second injection permitted at Week 8 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Intravitreal Triamcinolone 4mg
n=63 participants at risk
(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:
* 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
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.
|
Dexamethasoneintravitreal Implant
n=64 participants at risk
Dexamethasone intravitreal implant (Ozurdex) (0.7 mg) Initial injection at Week 0
Second injection permitted at Week 12 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;
* IOP of ≤21 or mm Hg and treatment with ≤3 IOP-lowering agents;
Dexamethasone intravitreal implant: • Standard preparation as described for intravitreal injections.
|
|---|---|---|---|
|
Eye disorders
Choroidal
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
Eye disorders
Ocular hypertension
|
1.5%
1/65 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Eye disorders
uveitis
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
Gastrointestinal disorders
colitis
|
1.5%
1/65 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Gastrointestinal disorders
gastric polyps
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
General disorders
injection site injury
|
1.5%
1/65 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Infections and infestations
pneumonia
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/65 • 24 weeks of follow-up
|
3.2%
2/63 • Number of events 2 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Investigations
mediastinoscopy
|
0.00%
0/65 • 24 weeks of follow-up
|
1.6%
1/63 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Musculoskeletal and connective tissue disorders
bursitis
|
1.5%
1/65 • Number of events 2 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive pulmonary disease
|
0.00%
0/65 • 24 weeks of follow-up
|
1.6%
1/63 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
0.00%
0/65 • 24 weeks of follow-up
|
1.6%
1/63 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Surgical and medical procedures
knee arthroplasty
|
1.5%
1/65 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
|
Surgical and medical procedures
shoulder arthroplasty
|
0.00%
0/65 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
1.6%
1/64 • Number of events 1 • 24 weeks of follow-up
|
|
Investigations
Investigation
|
1.5%
1/65 • Number of events 1 • 24 weeks of follow-up
|
0.00%
0/63 • 24 weeks of follow-up
|
0.00%
0/64 • 24 weeks of follow-up
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place