| Primary | Proportion of Baseline Central Subfield Thickness Observed at 8 Weeks | 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. | All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized") | Posted | | Mean | 99.87% Confidence Interval | proportion of baseline retinal thickness | | At baseline and 8 weeks | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | Units | Counts |
|---|
| Participants | | | Eyes with uveitis macular edema | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000.77(.67 to .89)
- OG001.61(.53 to .70)
- OG002.54(.46 to .63)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | mixed effects model | | <0.0001 | Two sided type I error threshold was 0.00132 since recruitment was halted after the single pre-planned interim analysis | Ratio of the proportion of BL | 0.79 | | | 2-Sided | 99.87 | .65 | .96 | | | Ratio of intravitreal over periocular | | Superiority | | | |
|
| Secondary | Proportion of Baseline Central Subfield Thickness Observed at 24 Weeks | 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. | All eyes with uveitic macular edema at randomization according to assigned treatment ("as randomized") | Posted | | Mean | 99.87% Confidence Interval | proportion of baseline retinal thickness | | At baseline and the 24 week visit | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | |
|
| Secondary | Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 8 Weeks | Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 8 weeks. | | Posted | | Number | 95% Confidence Interval | Proportion of eyes | | Over 8 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Proportion of Eyes With >= 20% Reduction in Macular Thickness (or Normalization Even if <20% Reduction) at 24 Weeks | Proportion of eyes with >=20% reduction in macular thickness (or normalization of macular thickness even if there is <20% reduction) at 24 weeks | | Posted | | Number | 95% Confidence Interval | Proportion of eyes | | Over 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Proportion of Eyes With Resolution of Macular Edema at 8 Weeks | Proportion 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. | | Posted | | Number | 95% Confidence Interval | Proportion of eyes | | Over 8 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Proportion of Eyes With Resolution of Macular Edema at 24 Weeks | Proportion 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. | | Posted | | Number | 95% Confidence Interval | Proportion of eyes | | Over 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Change in Best-corrected Visual Acuity at 8 Weeks | Mean 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. | | Posted | | Mean | 95% Confidence Interval | Standard letters | | Over 8 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Intravitreal Triamcinolone 4mg |
|
| Secondary | Change in Best-corrected Visual Acuity at 24 Weeks | Mean 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. | | Posted | | Mean | 95% Confidence Interval | Standard letters | | Over 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Intravitreal Triamcinolone 4mg |
|
| Secondary | Number of Eyes With Vitreous Hemorrhage | Count of eyes with vitreous hemorrhage as an immediate complication of injection. | | Posted | | Number | | Eyes with uveitic macular edema | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Eyes With Retinal Tear or Detachment | Count of eyes with retinal tears or detachments during the course of follow-up. | | Posted | | Number | | Eyes with uveitic macular edema | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Number of Eyes With Endophthalmitis | Count of eyes with an occurrence of endophthalmitis | | Posted | | Number | | Eyes with uveitic macular edema | | During 24 weeks of folllow-ip | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Cumulative Proportion of Eyes With Severe Vision Loss | Cumulative proportion of eyes with uveitic macular edema who experience severe vision loss (>= 15 standard letters) during the 24 weeks of follow-up. | | Posted | | Number | 95% Confidence Interval | Cumulative proportion of eyes at 24 wks | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Cumulative Proportion of Eyes With an IOP Elevation of >=10 mm Hg Over Baseline | Cumulative 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. | | Posted | | Number | 95% Confidence Interval | Cumulative proportion of eyes at 24 wks | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Cumulative Proportion of Eyes With an IOP Elevation >=24 mm Hg | Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=24 mm Hg during 24 weeks of follow-up. | | Posted | | Number | 95% Confidence Interval | Cumulative proportion of eyes at 24 wks | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Cumulative Proportion of Eyes With an IOP Elevation >=30 mm Hg | Cumulative proportion of eyes with uveitic macular edema that experience elevated IOP to >=30 mm Hg during 24 weeks of follow-up. | | Posted | | Number | 95% Confidence Interval | Cumulative proportion of eyes at 24 wks | | During 24 weeks of follow-up | Eyes with uveitis macular edema | Eyes with uveitis macular edema | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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