Age Related Macular Degeneration
Conditions
Brief summary
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.
Interventions
DRUGRanibizumab (Lucentis, Novartis Pharma GmbH, Germany)
Monthly intravitreal injections
Sponsors
University Hospital, Bonn
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration * Written informed consent
Exclusion criteria
* Time of diagnosis more than 6 months before study recruitment * Ocular surgery of the study eye within 1 month before study recruitment * Extensive subretinal fibrosis or retinal atrophy of the study eye * Significant opacification of optical media of the study eye * Uncontrolled glaucoma of the study eye * Active ocular inflammation of the study eye * Best-corrected visual acuity of the contralateral eye below 20/200 * Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected Visual Acuity | 12 months | Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Morphology | 12 months | Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness |
| Vision-related Quality of Life | 12 months | 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. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 24 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 76.8 years STANDARD_DEVIATION 5.2 |
| Best-corrected visual acuity | 50.3 ETDRS letters STANDARD_DEVIATION 18.7 |
| Central retinal thickness | 571 µm STANDARD_DEVIATION 185 |
| Region of Enrollment Germany | 24 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 14 Participants |
| Vision-related quality of life | 79.0 NEI VFQ-25 score STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Best-corrected Visual Acuity
Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Best-corrected Visual Acuity | 52.9 ETDRS letters | Standard Deviation 19.7 |
Secondary
Retinal Morphology
Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Retinal Morphology | 436 µm | Standard Deviation 171 |
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Vision-related Quality of Life | 74.3 NEI VFQ-25 score | Standard Deviation 13.9 |