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The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany) | Drug | Monthly intravitreal injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected Visual Acuity | Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Morphology | Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness | 12 months |
| Vision-related Quality of Life | National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25) 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bonn, Department of Ophthalmology | Bonn | 53127 | Germany | |||
| University of München (LMU), Department of Ophthalmology |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ranibizumab | Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ranibizumab | Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections |
| 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 | Best-corrected Visual Acuity | Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol | Posted | Mean | Standard Deviation | ETDRS letters | 12 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 | Ranibizumab | Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase of subretinal hemorrhage | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tim U. Krohne, MD, FEBO | Dept of Ophthalmology, University of Bonn, Bonn, Germany | +49 228 287 | 15505 | krohne@uni-bonn.de |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 12 months |
| München |
| 80336 |
| Germany |
| Universityof Münster, Department of Ophthalmology | Münster | 48149 | Germany |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Best-corrected visual acuity | Mean | Standard Deviation | ETDRS letters |
|
| Central retinal thickness | Mean | Standard Deviation | µm |
|
| Vision-related quality of life | National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25) 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8. | Mean | Standard Deviation | NEI VFQ-25 score |
|
|
| Secondary | Retinal Morphology | Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness | Posted | Mean | Standard Deviation | µm | 12 months |
|
|
|
| Secondary | Vision-related Quality of Life | National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25) 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8. | Posted | Mean | Standard Deviation | NEI VFQ-25 score | 12 months |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |