Age Related Macular Degeneration, Retinal Vein Occlusion
Conditions
Brief summary
Ranibizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody fragment approved in Chile by the Instituto de Salud Pública for the treatment of diabetic macular edema (DME), retinal vein occlusion and age-related macular degeneration. Currently, there is limited epidemiologic information in Chile regarding the incidence of DME and limited experience of anti-VEGF hospital therapy. This study will evaluate the efficacy of intravitreal ranibizumab in Chilean DME patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-VEGF in the treatment of diabetic macular edema.
Interventions
DRUGRanibizumab Intravitreal injections
Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or OCT) in at least one eye. 2. Vision impairment due to DME (BCVA ETDRS letter score at 4 meters between 20 and 70 letters (6/12 - 3/60 at Snellen chart).
Exclusion criteria
1. Laser photocoagulation in the study eye for the last 3 months. 2. Any history of any intraocular surgery in the study eye within the past 3 months. 3. Blood pressure \>160/100 mmHg. 4. Proliferative Diabetic Retinopathy. Any other protocol inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Best Correct Visual Acuity (BCVA) | baseline, week 48 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Baseline, Week 4, 8, 12, 24 and 36 | BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement. |
| Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) | Baseline, week 48 | Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease. |
| Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period. | Week 48 | — |
| Number of Participants With Letters Gain / Loss at Week 52 | Baseline, Week 52 | Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters. |
| Change in Mean Visual Function Questionnaire (VFQ-25) | Baseline, week 48 | Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening. |
Countries
Chile
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ranibizumab Ranibizumab 0.5 mg administered as an intravitreal injection | 21 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Ranibizumab |
|---|---|
| Age, Continuous | 64.43 Years STANDARD_DEVIATION 8.44 |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 17 / 21 |
| serious Total, serious adverse events | 6 / 21 |
Outcome results
Primary
Mean Change From Baseline in Best Correct Visual Acuity (BCVA)
Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.
Time frame: baseline, week 48
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ranibizumab | Mean Change From Baseline in Best Correct Visual Acuity (BCVA) | 9.55 Letters | Standard Deviation 6.57 |
Secondary
Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. A positive change from baseline indicated improvement.
Time frame: Baseline, Week 4, 8, 12, 24 and 36
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Week 4 | 5.65 Letters | Standard Deviation 5.25 |
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Week 8 | 6.90 Letters | Standard Deviation 4.27 |
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Week 12 | 8.50 Letters | Standard Deviation 6.13 |
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Week 24 | 8.05 Letters | Standard Deviation 7.32 |
| Ranibizumab | Change From Baseline in Best-corrected Visual Acuity (BCVA) After Week 4, 8, 12, 24 and 36 | Week 36 | 8.40 Letters | Standard Deviation 7.18 |
Secondary
Change in Mean Visual Function Questionnaire (VFQ-25)
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
Time frame: Baseline, week 48
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | General health | 12.50 Score on a scale | Standard Deviation 28.68 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | General vision | 13 Score on a scale | Standard Deviation 14.9 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Ocular pain | 11.88 Score on a scale | Standard Deviation 23.81 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Near activities | 7.50 Score on a scale | Standard Deviation 16.64 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Distance activities | 9.62 Score on a scale | Standard Deviation 16.26 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Social Functioning | 13.13 Score on a scale | Standard Deviation 15.95 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Mental health | 9.69 Score on a scale | Standard Deviation 31.9 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Role difficulties | 10.63 Score on a scale | Standard Deviation 34.24 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Dependency | 13.75 Score on a scale | Standard Deviation 26.94 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Driving | -0.0 Score on a scale | Standard Deviation 22.05 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Color vision | 15 Score on a scale | Standard Deviation 27.39 |
| Ranibizumab | Change in Mean Visual Function Questionnaire (VFQ-25) | Peripheral vision | 7.50 Score on a scale | Standard Deviation 31.52 |
Secondary
Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT)
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation, an increase in thickness as compared to baseline may indicate a progression of the underlying disease.
Time frame: Baseline, week 48
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ranibizumab | Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) | Right eye | 388.50 Microns | Standard Deviation 151.39 |
| Ranibizumab | Change Over Time of the Intraretinal Thickness in Optical Coherence Tomography (OCT) | Left eye | 367.06 Microns | Standard Deviation 91.44 |
Secondary
Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period.
Time frame: Week 48
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ranibizumab | Number of Participants Receiving Injections of Ranibizumab 0.5 mg Over a 48 Week Treatment Period. | 7 Count of participants |
Secondary
Number of Participants With Letters Gain / Loss at Week 52
Number of participants with letters correctly identified were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time frame: Baseline, Week 52
Population: Full Analysis Set (FAS) include all patients who received at least one dose of study medication, and have at least one post-baseline efficacy assessment. The FAS is analyzed according to the intention to treat ideal
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 5 or more letters gained | 14 Count of Participants |
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 10 or more letters gained | 8 Count of Participants |
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 15 or more letters gained | 5 Count of Participants |
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 5 or more letters lost | 0 Count of Participants |
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 10 or more letters lost | 0 Count of Participants |
| Ranibizumab | Number of Participants With Letters Gain / Loss at Week 52 | 15 or more letters lost | 0 Count of Participants |