Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pfizer Reference # 20050548 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Eyetech Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.
Retinal venous occlusive disease, which includes central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO), is second only to diabetic retinopathy as a cause of vision loss due to retinal disease. The main cause of vision loss in all of these disorders is the development of macular edema. Current clinical practice based on randomized controlled clinical trials (ETDRS, BVOS) employs laser photocoagulation, either in a focal or grid pattern, to treat macular edema associated with diabetic retinopathy and branch retinal vein occlusion. Unfortunately, laser photocoagulation is ineffective in central retinal vein occlusion (CRVO), and no proven therapy exists for CRVO.
The pathogenesis of macular edema in retinal vascular diseases is generally accepted to be increased levels of vascular endothelial growth factor (VEGF) due to ischemic or other stimuli. VEGF is known to be one of the most potent stimulators of vascular leakage in humans. Therefore, it seems sensible to study inhibition of VEGF to reduce vascular leakage, reduce macular edema, and improve vision in these retinal vascular disorders.
Phase 2 randomized, controlled clinical trials of Macugen in diabetic macular edema and in macular edema associated with CRVO have been conducted. In the diabetes trial, patients treated with Macugen had improved vision, reduced macular edema as measured by optical coherence tomography (OCT), and reduced need for laser treatment compared to patients treated with sham injections. In the CRVO trial, patients treated with Macugen 1 mg every 6 weeks for 24 weeks had improved vision and reduced macular edema at week 30 compared to sham. This is the first randomized trial of treatment for CRVO to show a benefit over control. Based on these positive findings, we plan to study Macugen treatment of macular edema due to BRVO.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegaptanib Sodium 0.3mg (Macugen) | Active Comparator | Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. |
|
| Pegaptanib Sodium 1 mg (Macugen) | Active Comparator | Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegaptanib sodium (Macugen) | Drug | Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks | 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield | 54 Weeks | |
| Safety Parameters | Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John A Wells, III, MD | Palmetto Retina Center, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute | Los Angeles | California | 90095 | United States | ||
| Cumberland Valley Retina Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2866759 | Background | Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806. | |
| 6383055 | Background | Argon laser photocoagulation for macular edema in branch vein occlusion. The Branch Vein Occlusion Study Group. Am J Ophthalmol. 1984 Sep 15;98(3):271-82. doi: 10.1016/0002-9394(84)90316-7. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pegaptanib Sodium 0.3mg (Macugen) | |
| FG001 | Pegaptanib Sodium 1 mg (Macugen) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pegaptanib Sodium 0.3mg (Macugen) | Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. |
| BG001 | Pegaptanib Sodium 1 mg (Macugen) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in ETDRS Best Corrected Visual Acuity From Baseline at 54 Weeks | Posted | Mean | Standard Deviation | ETDRS letters | 54 Weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pegaptanib Sodium 0.3mg (Macugen) | Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| retinal detachment | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John A. Wells, III, M.D. | Palmetto Retina Center | 803-931-0077 | jackwells@palmettoretina.com |
Not provided
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
Not provided
Not provided
| ID | Term |
|---|---|
| C495058 | pegaptanib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 54 Weeks |
| Change in Central Subfield Thickness on OCT From Baseline to Week 54 | 54 Weeks |
| Change in Macular Volume on OCT From Baseline to Week 54 | 54 Weeks |
| Hagerstown |
| Maryland |
| 21740 |
| United States |
| Palmetto Retina Center | West Columbia | South Carolina | 29169 | United States |
| 9097788 | Background | Evaluation of grid pattern photocoagulation for macular edema in central vein occlusion. The Central Vein Occlusion Study Group M report. Ophthalmology. 1995 Oct;102(10):1425-33. doi: 10.1016/s0161-6420(95)30849-4. |
| 16154196 | Background | Cunningham ET Jr, Adamis AP, Altaweel M, Aiello LP, Bressler NM, D'Amico DJ, Goldbaum M, Guyer DR, Katz B, Patel M, Schwartz SD; Macugen Diabetic Retinopathy Study Group. A phase II randomized double-masked trial of pegaptanib, an anti-vascular endothelial growth factor aptamer, for diabetic macular edema. Ophthalmology. 2005 Oct;112(10):1747-57. doi: 10.1016/j.ophtha.2005.06.007. |
| 7526212 | Background | Aiello LP, Avery RL, Arrigg PG, Keyt BA, Jampel HD, Shah ST, Pasquale LR, Thieme H, Iwamoto MA, Park JE, et al. Vascular endothelial growth factor in ocular fluid of patients with diabetic retinopathy and other retinal disorders. N Engl J Med. 1994 Dec 1;331(22):1480-7. doi: 10.1056/NEJM199412013312203. |
| 11931788 | Background | Funatsu H, Yamashita H, Ikeda T, Nakanishi Y, Kitano S, Hori S. Angiotensin II and vascular endothelial growth factor in the vitreous fluid of patients with diabetic macular edema and other retinal disorders. Am J Ophthalmol. 2002 Apr;133(4):537-43. doi: 10.1016/s0002-9394(02)01323-5. |
Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Standardized Change From Baseline in Macular Thickening Measured by OCT3 Using the Central Point of the Central Subfield | Fifteen patients were enrolled in the pegaptanib 0.3 mg dose group and 5 patients were enrolled in the 1.0 mg dose group. | Posted | Mean | Standard Deviation | microns | 54 Weeks |
|
|
|
| Secondary | Safety Parameters | Safety endpoints incuded all investigator reported ocular and systemic adverse events. All events were graded as mild moderate or severe and assessed as related or unrelated to the injection procedure and the study drug. | Posted | Number | percentage of participants | 54 Weeks |
|
|
|
| Secondary | Change in Central Subfield Thickness on OCT From Baseline to Week 54 | Posted | Mean | Standard Deviation | microns | 54 Weeks |
|
|
|
| Secondary | Change in Macular Volume on OCT From Baseline to Week 54 | Posted | Mean | Standard Deviation | mm cubed | 54 Weeks |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| EG001 | Pegaptanib Sodium 1 mg (Macugen) | Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54. | 0 | 5 | 0 | 5 |
Not provided
Not provided
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |