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To compare the effect of intravitreal-Bevacizumab and Triamcinolone with intravitreal-Bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. |
|
| Group B | Active Comparator | Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A | Drug | Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Change in visual acuity | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Foveal Thickness | change in central foveal thickness | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayatabad Medical Complex | Peshawar | KPK | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26107597 | Background | Yoshizawa C, Saito W, Kase M, Ishida S. Clinical Features of Central Retinal Vein Occlusion With Inflammatory Etiology. Asia Pac J Ophthalmol (Phila). 2012 Sep-Oct;1(5):270-6. doi: 10.1097/APO.0b013e318266de04. | |
| 21305727 | Background | Lazic R, Boras I, Vlasic M, Gabric N, Tomic Z. Anti-VEGF in treatment of central retinal vein occlusion. Coll Antropol. 2010 Apr;34 Suppl 2:69-72. |
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All enrolled participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) |
| FG001 | Group B | Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | Change in visual acuity | Posted | Mean | Standard Deviation | logMAR units | Baseline and 6 months |
|
6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combination Group | A single injection of triamcinolone acetonide (Kenacort-AⓇ). (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) was given at the start of the treatment whereas intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yousaf Jamal Mahsood | Hayatabad Medical Complex, Peshawar | 091921714047 | yousaf82@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 7, 2018 | Apr 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| BG001 | Group B | Intravitreal bevacizumab (1.25mg/0.05ml) was repeated monthly for 3 months. Group A: Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Visual acuity | Mean | Standard Deviation | logMAR units |
|
| central foveal thickness | Mean | Standard Deviation | microns |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Central Foveal Thickness | change in central foveal thickness | Posted | Mean | Standard Deviation | microns | Baseline and 6 months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Standard Group | group B received IVB (1.25mg/0.05ml) alone | 0 | 15 | 0 | 15 | 0 | 15 |
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| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |