Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021662-30 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab driven by disease activity | Experimental | Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria |
|
| Ranibizumab driven by stabilization criteria | Experimental | Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity |
|
| Verteporfin PDT | Active Comparator | Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | 0.5 mg ranibizumab intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3. | Baseline, Month 1 through Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Vienna | Austria | 1090 | Austria | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25109929 | Derived | Ceklic L, Wolf-Schnurrbusch U, Gekkieva M, Wolf S. Visual acuity outcome in RADIANCE study patients with dome-shaped macular features. Ophthalmology. 2014 Nov;121(11):2288-9. doi: 10.1016/j.ophtha.2014.06.012. Epub 2014 Aug 8. No abstract available. | |
| 24326106 | Derived | Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M; RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2. doi: 10.1016/j.ophtha.2013.10.023. Epub 2013 Dec 8. |
Not provided
Not provided
Not provided
Out of the 334 patients screened, 277 patients were randomized into the study on a 2:2:1 basis: 106 patients to Group I (treatment with ranibizumab according to visual acuity stabilization), 116 patients to Group II (ranibizumab treatment according to disease activity), and 55 patients to Group III (treatment with vPDT)
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA). |
| FG001 | 0.5mg Ranibizumab Driven by Disease Activity |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Verteporfin PDT | Drug | Verteporfin (6 mg/m2) intravenous infusion |
|
|
| Sham Ranibizumab | Drug | Empty vial to mimic the intravitreal injection |
|
| Sham verteporfin PDT | Drug | Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT). |
|
| Baseline and Month 6 |
| Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12 | Baseline and Month 1 through Month 12 |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3. | Month 3 |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12. | Months 6 and 12 |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3. | Month 3 |
| Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12. | Months 6 and 12 |
| Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators. | Baseline, Month 3, Month 6 and Month 12 |
| Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators. | Baseline and Month 12 |
| Number of Ranibizumab Injections Received Prior to Month 3 | In order to describe exposure to the study drug the number of ejections was evaluated | Day 1 and prior to month 3 |
| Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period | Day 1 prior to month 6 and prior to month 12 |
| Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period | Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period. | Month 3 up to month 12 |
| Linz |
| Upper Austria |
| 4021 |
| Austria |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 3N9 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Bordeaux | France | F-33076 | France |
| Novartis Investigative Site | Dijon | 21033 | France |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Reims | 51092 | France |
| Novartis Investigative Site | Toulouse | 31059 | France |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | München | 81675 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Nuremberg | 90491 | Germany |
| Novartis Investigative Site | Regensburg | 93053 | Germany |
| Novartis Investigative Site | Hong Kong | Hong Kong | Hong Kong |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Debrecen | 4004 | Hungary |
| Novartis Investigative Site | Mumbai | Maharashtra | 400031 | India |
| Novartis Investigative Site | New Delhi | New Delhi | 110 029 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 600006 | India |
| Novartis Investigative Site | Madurai | Tamil Nadu | 625020 | India |
| Novartis Investigative Site | Bangalore | 560010 | India |
| Novartis Investigative Site | Bari | BA | 70124 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Milan | MI | 20157 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 466-8560 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 467-8602 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-8582 | Japan |
| Novartis Investigative Site | Fukushima | Fukushima | 960-1295 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Kita-gun | Kagawa-ken | 761-0793 | Japan |
| Novartis Investigative Site | Kyoto | Kyoto | 606-8507 | Japan |
| Novartis Investigative Site | Matsumoto | Nagano | 390-8621 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-1191 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Novartis Investigative Site | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| Novartis Investigative Site | Chiyoda-ku | Tokyo | 101-8309 | Japan |
| Novartis Investigative Site | Mitaka | Tokyo | 181-8611 | Japan |
| Novartis Investigative Site | Riga | 1002 | Latvia |
| Novartis Investigative Site | Kaunas | LT-50009 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Bielsko-Biala | 43-300 | Poland |
| Novartis Investigative Site | Coimbra | 3000-075 | Portugal |
| Novartis Investigative Site | Porto | 4200-319 | Portugal |
| Novartis Investigative Site | Singapore | Singapore | 308433 | Singapore |
| Novartis Investigative Site | Singapore | Singapore | 768825 | Singapore |
| Novartis Investigative Site | Singapore | 168751 | Singapore |
| Novartis Investigative Site | Banská Bystrica | Slovak Republic | 975 17 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 82606 | Slovakia |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 135-710 | South Korea |
| Novartis Investigative Site | Seoul | 738-736 | South Korea |
| Novartis Investigative Site | Bilbao | Basque Country | 48006 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | L'Hospitalet de Llobregat | Catalonia | 08907 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03016 | Spain |
| Novartis Investigative Site | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Geneva | 1204 | Switzerland |
| Novartis Investigative Site | Lausanne | 1007 | Switzerland |
| Novartis Investigative Site | Ankara | Turkey | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Turkey | 06490 | Turkey (Türkiye) |
| Novartis Investigative Site | Etlik / Ankara | 06018 | Turkey (Türkiye) |
| Novartis Investigative Site | Belfast | BT12 6BA | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 2LX | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria |
| FG002 | Verteporfin PDT | Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. |
| Completed 3 Months |
|
| Completed 6 Months |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA). |
| BG001 | 0.5mg Ranibizumab Driven by Disease Activity | Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria |
| BG002 | Verteporfin PDT | Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Mean | Standard Deviation | Letters | Baseline, Month 1 through Month 3 |
|
|
| ||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Mean | Standard Deviation | Letters | Baseline and Month 6 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye | The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12 | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Mean | Standard Deviation | Letters | Baseline and Month 1 through Month 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Number | Percentage of Patients | Month 3 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Number | Percentage of Patients | Months 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Number | Percentage of Patients | Month 3 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Number | Percentage of Patients | Months 6 and 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Retinal Thickness of the Study Eye Over Time | Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Mean | Standard Deviation | Microns | Baseline, Month 3, Month 6 and Month 12 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye | CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators. | Participants from the Full Analysis Set, included all participants who received at least one dose of study drug, with data available for analysis. Missing data were imputed with Last Observation Carried Forward | Posted | Number | Percentage of Patients | Baseline and Month 12 |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Ranibizumab Injections Received Prior to Month 3 | In order to describe exposure to the study drug the number of ejections was evaluated | The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment | Posted | Mean | Standard Deviation | injections | Day 1 and prior to month 3 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period | Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period | The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment | Posted | Mean | Standard Deviation | injections | Day 1 prior to month 6 and prior to month 12 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period | Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period. | The Safety Set consisted of all patients who received at least one application of study treatment (ranibizumab [sham] and/or vPDT [sham]) and had at least one post-baseline safety assessment. | Posted | Mean | Standard Deviation | injections | Month 3 up to month 12 |
|
|
Not provided
Two participants who were randomized to Visudyne PDT received 0.5mg Ranibizumab and were followed up in the group "Driven by Disease Activity" therefore, the total of participants at risk in the safety section is discrepant by a number of 2 in each of these groups.
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 | 0.5 mg Ranibizumab Driven by Stabilization Criteria | Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA). | 7 | 106 | 46 | 106 | ||
| EG001 | 0.5mg Ranibizumab Driven by Disease Activity | Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria | 6 | 118 | 47 | 118 | ||
| EG002 | Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3 | After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed. | 0 | 38 | 17 | 38 | ||
| EG003 | Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3 | After month 3 participants did not receive active ranibizumab | 0 | 15 | 8 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Corneal erosion (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Retinoschisis (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Blindness (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival hyperaemia (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular hypertension (Fellow eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Punctate keratitis (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Visual impairment (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Vitreous detachment (Study eye) | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Injection site haemorrhage (Study eye) | General disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis viral (Study eye) | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA | Systematic Assessment |
| |
| Myositis (Study eye) | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D009216 | Myopia |
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| 45 -< 55 years |
|
| 55-<65 years |
|
| >=65 |
|
| Male |
|
|
|
|
|
|
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
|
|
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
|
|
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
|
|
Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|