Macular Edema, Cystoid, Retinal Vein Occlusion
Conditions
Keywords
macular edema, central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO)
Brief summary
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Detailed description
Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and BRVO are common retinal problems and are caused by a blockage in one of the large retinal veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein occlusion - BRVO). Currently, there is no effective treatment for macular edema associated with CRVO and standard care treatment is observation. Grid laser photocoagulation may be effective for some patients for macular edema associated with BRVO, but many patients derive limited benefit from this treatment. Therefore, the development of new treatment modalities for macular edema caused by these two conditions is an important research goal. Over the last several years, many patients with macular edema from CRVO and BRVO have been treated with an injection of a type of steroid called triamcinolone directly into the eye. This type of injection is called an intravitreal injection. The triamcinolone preparation commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and joints. The SCORE Study will use a formulation of triamcinolone made specifically for the eye. The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness and safety of standard care versus triamcinolone injection(s) for the treatment of macular edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will be randomized (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After randomization, participants will be examined every 4 months through 3 years to collect ophthalmic information, including visual acuity, intraocular pressure, optical coherence tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and 24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be provided as clinically indicated based on protocol-specific guidelines. The primary outcome is improvement by 15 or more letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as assessed by stereoscopic color fundus photography and optical coherence tomography, and adverse ocular outcomes.
Interventions
OTHERStandard Care
CRVO: observation; BRVO: standard care
1 mg dose
Sponsors
National Eye Institute (NEI)
Allergan
The Emmes Company, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). * Individuals, 18 years of age or older, willing to provide consent may be eligible for the SCORE Study.
Exclusion criteria
refer to SCORE Study website at https://web.emmes.com/study/score/ for listing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | Change from baseline to 12 months | Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart. |
Secondary
| Measure | Time frame |
|---|---|
| Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | 12 months |
| Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | 12 months |
| Adverse Ocular Outcomes | 12 months |
Countries
United States
Participant flow
Recruitment details
Between November 8, 2004, and February 29, 2008, 271 patients with central retinal vein occlusion (CRVO) were enrolled from 66 clinical sites and 411 patients with branch retinal vein occlusion (BRVO) were enrolled from 75 clinical sites across the United States. Participant flow data are reported for the primary outcome measure (12 months).
Participants by arm
| Arm | Count |
|---|---|
| CRVO Observation Standard care consists of observation of the macular edema. | 88 |
| CRVO 1 mg Dose Triamcinolone Acetonide Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | 92 |
| CRVO 4 mg Dose Triamcinolone Acetonide Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | 91 |
| BRVO Standard Care Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment. | 137 |
| BRVO 1 mg Dose Triamcinolone Acetonide Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | 136 |
| BRVO 4 mg Dose Triamcinolone Acetonide Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg). | 138 |
| Total | 682 |
Baseline characteristics
| Characteristic | CRVO 1 mg Dose Triamcinolone Acetonide | CRVO 4 mg Dose Triamcinolone Acetonide | BRVO Standard Care | CRVO Observation | BRVO 1 mg Dose Triamcinolone Acetonide | BRVO 4 mg Dose Triamcinolone Acetonide | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 57 Participants | 75 Participants | 63 Participants | 82 Participants | 83 Participants | 417 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 34 Participants | 62 Participants | 25 Participants | 54 Participants | 55 Participants | 265 Participants |
| Age, Continuous | 67.4 years STANDARD_DEVIATION 12.4 | 67.5 years STANDARD_DEVIATION 12 | 66.9 years STANDARD_DEVIATION 11.5 | 69.2 years STANDARD_DEVIATION 12.8 | 67.2 years STANDARD_DEVIATION 11.5 | 68.1 years STANDARD_DEVIATION 10.6 | 67.7 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 92 participants | 91 participants | 137 participants | 88 participants | 136 participants | 138 participants | 682 participants |
| Sex: Female, Male Female | 43 Participants | 40 Participants | 71 Participants | 40 Participants | 68 Participants | 63 Participants | 325 Participants |
| Sex: Female, Male Male | 49 Participants | 51 Participants | 66 Participants | 48 Participants | 68 Participants | 75 Participants | 357 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 88 | 1 / 92 | 2 / 91 | 3 / 137 | 2 / 136 | 2 / 138 |
| other Total, other adverse events | 76 / 88 | 87 / 92 | 89 / 91 | 118 / 137 | 132 / 136 | 133 / 138 |
| serious Total, serious adverse events | 32 / 88 | 37 / 92 | 53 / 91 | 47 / 137 | 49 / 136 | 79 / 138 |
Outcome results
Primary
The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit
Visual acuity testing was done using electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity testing at 3 meters using the Electronic Visual Acuity Tester by a SCORE certified technician. A masked visual acuity examiner with no knowledge of treatment assignments performed visual acuity testing at the 4-month, 12-month, 24-month and 36-month visits. An E-ETDRS visual acuity score of 85 is approximately 20/20, and a score of 20 letters is approximately 20/400. A visual acuity letter score change of 15 is about three lines on a vision chart.
Time frame: Change from baseline to 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CRVO Observation | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 5 Participants |
| CRVO 1 mg Dose Triamcinolone Acetonide | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 22 Participants |
| CRVO 4 mg Dose Triamcinolone Acetonide | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 21 Participants |
| BRVO Standard Care | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 35 Participants |
| BRVO 1 mg Dose Triamcinolone Acetonide | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 31 Participants |
| BRVO 4 mg Dose Triamcinolone Acetonide | The Number of Study Participants Experiencing an Improvement by 15 or More Letters From Baseline in Best-corrected ETDRS Visual Acuity Score at the 12-month Visit | 34 Participants |
Secondary
Adverse Ocular Outcomes
Time frame: 12 months
Population: Participants experiencing an adverse event
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CRVO Observation | Adverse Ocular Outcomes | Iris neovascularization | 2 events |
| CRVO Observation | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 2 events |
| CRVO Observation | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 12 events |
| CRVO Observation | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 7 events |
| CRVO Observation | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 5 events |
| CRVO Observation | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | Laser peripheral iridotomy | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | Cataract surgery | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | YAG capsulotomy | 1 events |
| CRVO Observation | Adverse Ocular Outcomes | Retinal detachment | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | Pars plana vitrectomy | 1 events |
| CRVO Observation | Adverse Ocular Outcomes | IOP > 35 mm HG | 1 events |
| CRVO Observation | Adverse Ocular Outcomes | Retinal neovascularization | 4 events |
| CRVO Observation | Adverse Ocular Outcomes | Vitreous hemorrhage | 4 events |
| CRVO Observation | Adverse Ocular Outcomes | Infectious endophthalmitis | 0 events |
| CRVO Observation | Adverse Ocular Outcomes | Tube shunt | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Iris neovascularization | 9 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Infectious endophthalmitis | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Pars plana vitrectomy | 2 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal detachment | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 35 mm HG | 5 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 9 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 15 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Laser peripheral iridotomy | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | YAG capsulotomy | 0 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Vitreous hemorrhage | 4 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Tube shunt | 2 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 18 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 20 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal neovascularization | 2 events |
| CRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract surgery | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Vitreous hemorrhage | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 32 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 3 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract surgery | 4 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Tube shunt | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Infectious endophthalmitis | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 35 mm HG | 8 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal neovascularization | 2 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal detachment | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Iris neovascularization | 4 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Pars plana vitrectomy | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 25 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Laser peripheral iridotomy | 1 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | YAG capsulotomy | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| CRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 24 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Cataract surgery | 3 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 3 events |
| BRVO Standard Care | Adverse Ocular Outcomes | IOP > 35 mm HG | 1 events |
| BRVO Standard Care | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 1 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Laser peripheral iridotomy | 0 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Tube shunt | 0 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 15 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Vitreous hemorrhage | 2 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Infectious endophthalmitis | 0 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Retinal detachment | 1 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Iris neovascularization | 1 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Retinal neovascularization | 5 events |
| BRVO Standard Care | Adverse Ocular Outcomes | YAG capsulotomy | 1 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 5 events |
| BRVO Standard Care | Adverse Ocular Outcomes | Pars plana vitrectomy | 1 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Infectious endophthalmitis | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract surgery | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 11 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Iris neovascularization | 1 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 27 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal neovascularization | 1 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Tube shunt | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Vitreous hemorrhage | 1 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Laser peripheral iridotomy | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | YAG capsulotomy | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 12 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 35 mm HG | 2 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Pars plana vitrectomy | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 1 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| BRVO 1 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal detachment | 1 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract surgery | 4 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 10 mm HG above baseline | 50 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Pars plana vitrectomy | 1 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Sector or panretinal photocagulation | 4 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Iris neovascularization | 2 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Cataract: lens opacity onset or progression | 38 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | YAG capsulotomy | 1 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Tube shunt | 0 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Infectious endophthalmitis | 1 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Noninfectious endophthalmitis | 0 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal neovascularization | 3 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | IOP > 35 mm HG | 14 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Trabeculectomy | 0 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Retinal detachment | 0 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Initiation of IOP-lowering medications | 57 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Vitreous hemorrhage | 3 events |
| BRVO 4 mg Dose Triamcinolone Acetonide | Adverse Ocular Outcomes | Laser peripheral iridotomy | 1 events |
Secondary
Changes From Baseline in Best-corrected ETDRS Visual Acuity Score
Time frame: 12 months
Population: Participants who attended month 12 visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CRVO Observation | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | -12.1 letters read |
| CRVO 1 mg Dose Triamcinolone Acetonide | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | -1.2 letters read |
| CRVO 4 mg Dose Triamcinolone Acetonide | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | -1.2 letters read |
| BRVO Standard Care | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | 4.2 letters read |
| BRVO 1 mg Dose Triamcinolone Acetonide | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | 5.7 letters read |
| BRVO 4 mg Dose Triamcinolone Acetonide | Changes From Baseline in Best-corrected ETDRS Visual Acuity Score | 4.0 letters read |
Secondary
Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography
Time frame: 12 months
Population: Participants who attended month 12 visit
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CRVO Observation | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -277 um |
| CRVO 1 mg Dose Triamcinolone Acetonide | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -196 um |
| CRVO 4 mg Dose Triamcinolone Acetonide | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -261 um |
| BRVO Standard Care | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -224 um |
| BRVO 1 mg Dose Triamcinolone Acetonide | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -149 um |
| BRVO 4 mg Dose Triamcinolone Acetonide | Changes in Retinal Thickness as Assessed by Stereoscopic Color Fundus Photography and Optical Coherence Tomography | -170 um |