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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-004959-39 | EudraCT Number |
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This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections.
The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.
During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RBZ 0.5 mg: VA only (Group I) | Experimental | RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) |
|
| RBZ 0.5 mg: VA and/or OCT (Group II) | Experimental | RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug | Intravitreal injections of 0.5 mg Ranibizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye. | up to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Buenos Aires | C1122AAI | Argentina | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31918685 | Derived | Staurenghi G, Garweg JG, Gerendas BS, Macfadden W, Gekkiev B, Margaron P, Dunger-Baldauf C, Kolar P. Functional versus functional and anatomical criteria-guided ranibizumab treatment in patients with neovascular age-related macular degeneration - results from the randomized, phase IIIb OCTAVE study. BMC Ophthalmol. 2020 Jan 9;20(1):18. doi: 10.1186/s12886-019-1251-6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | RBZ 0.5 mg: VA Only (Group I) | RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) |
| FG001 | RBZ 0.5 mg: VA and/or OCT (Group II) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| up to Month 12 |
| Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Month 12 and 24 |
| Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Month 3 to Month 24 |
| Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Dry Retina in the Study Eye on OCT at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Month 12 and 24 |
| Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Treatment Patterns Over Time in Both Treatment Arms | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Baseline to Month 12 and 24 |
| Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Screening to Month 12 and 24 |
| Ciudad Autonoma de Bs As |
| C1015ABO |
| Argentina |
| Novartis Investigative Site | Vienna | 1090 | Austria |
| Novartis Investigative Site | Vancouver | British Columbia | V5Z 3N9 | Canada |
| Novartis Investigative Site | Halifax | Nova Scotia | B3H 2E1 | Canada |
| Novartis Investigative Site | London | Ontario | N6A 4G5 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Novartis Investigative Site | Boisbriand | Quebec | J7H 1S6 | Canada |
| Novartis Investigative Site | Sherbrooke | Quebec | J1J 2B8 | Canada |
| Novartis Investigative Site | Medellín | Antioquia | 001 | Colombia |
| Novartis Investigative Site | Bogotá | Cundinamarca | 7550000 | Colombia |
| Novartis Investigative Site | Olomouc | CZE | 775 20 | Czechia |
| Novartis Investigative Site | Brno | 625 00 | Czechia |
| Novartis Investigative Site | Hradec Králové | 505 05 | Czechia |
| Novartis Investigative Site | Prague | 100 34 | Czechia |
| Novartis Investigative Site | HUS | 00029 | Finland |
| Novartis Investigative Site | Kuopio | 70211 | Finland |
| Novartis Investigative Site | Paris | 75015 | France |
| Novartis Investigative Site | Bonn | 53127 | Germany |
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Darmstadt | 64297 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Regensburg | 93053 | Germany |
| Novartis Investigative Site | Ampelokipoi | Athens | 11 526 | Greece |
| Novartis Investigative Site | Glyfada | Athens | 16675 | Greece |
| Novartis Investigative Site | Athens | GR | 156 69 | Greece |
| Novartis Investigative Site | Ioannina | 45500 | Greece |
| Novartis Investigative Site | Guatemala City | 01009 | Guatemala |
| Novartis Investigative Site | Guatemala City | 01010 | Guatemala |
| Novartis Investigative Site | Budapest | 1076 | Hungary |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Budapest | 1106 | Hungary |
| Novartis Investigative Site | Budapest | 1133 | Hungary |
| Novartis Investigative Site | Budapest | 1145 | Hungary |
| Novartis Investigative Site | Debrecen | 4012 | Hungary |
| Novartis Investigative Site | Szeged | H-6725 | Hungary |
| Novartis Investigative Site | Veszprém | H-8200 | Hungary |
| Novartis Investigative Site | Zalaegerszeg | 8900 | Hungary |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Waterford | Ireland |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20100 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Kaunas | LTU | 50009 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Mexico City | Mexico City | 06800 | Mexico |
| Novartis Investigative Site | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Novartis Investigative Site | Nijmegen | 6525 EX | Netherlands |
| Novartis Investigative Site | Rotterdam | 3011 BH | Netherlands |
| Novartis Investigative Site | Panama City | 0819-12316 | Panama |
| Novartis Investigative Site | Coimbra | 3000-354 | Portugal |
| Novartis Investigative Site | Lisbon | 1050-085 | Portugal |
| Novartis Investigative Site | Porto | 4200-319 | Portugal |
| Novartis Investigative Site | Bratislava | 82606 | Slovakia |
| Novartis Investigative Site | Bratislava | 85107 | Slovakia |
| Novartis Investigative Site | Nitra | 94901 | Slovakia |
| Novartis Investigative Site | Trenčín | 91171 | Slovakia |
| Novartis Investigative Site | Zvolen | 960 01 | Slovakia |
| Novartis Investigative Site | Žilina | 01207 | Slovakia |
| Novartis Investigative Site | Bilbao | Basque Country | 48006 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33012 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Linköping | SE-581 85 | Sweden |
| Novartis Investigative Site | Bern | 3012 | Switzerland |
| Novartis Investigative Site | Geneva | 1204 | Switzerland |
| Novartis Investigative Site | Lausanne | 1007 | Switzerland |
| Novartis Investigative Site | Zurich | 8063 | Switzerland |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06490 | Turkey (Türkiye) |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | Belfast | BT12 6BA | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 2LX | United Kingdom |
| Novartis Investigative Site | Cheshire | CW14QJ | United Kingdom |
| Novartis Investigative Site | Derby | DE22 3NE | United Kingdom |
| Novartis Investigative Site | Gloucester | GL1 3NN | United Kingdom |
| Novartis Investigative Site | Great Yarmouth | NR31 6LA | United Kingdom |
| Novartis Investigative Site | Guildford, Surrey | GU2 5XX | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | London | EC1V 2PD | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Novartis Investigative Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novartis Investigative Site | Rugby | CV22 5PX | United Kingdom |
| Novartis Investigative Site | Southampton | SO16 6YD | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
| Novartis Investigative Site | York | YO31 8HE | United Kingdom |
RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). |
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RBZ 0.5 mg: VA Only (Group I) | RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) |
| BG001 | RBZ 0.5 mg: VA and/or OCT (Group II) | RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| 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 Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 | Visual acuity (VA) was assessed during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged up to Month 12 Level of VA (Letters) of the Study Eye. | Full Analysis Set (FAS) includes all randomized patients | Posted | Mean | Standard Deviation | Letters correctly read | up to Month 12 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Visual Acuity (Letters) of the Study Eye up to Month 12 | Visual acuity (VA) was assessed using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at a testing distance of 4 meters. This outcome measure describes the difference between the Visual Acuity averaged from Baseline to Month 12 Level of VA (Letters) of the Study Eye. | Full Analysis Set (FAS) includes all randomized patients | Posted | Mean | Standard Deviation | letters correctly read | up to Month 12 |
| ||||||||||||||||||||||||||||||
| Secondary | Gain of Equal or More Than 1, 5, 10, or 15 Letters in Visual Acuity of the Study Eye From Baseline, at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Loss of Less Than 5, 10, and 15 Letters in Visual Acuity in the Study Eye From Baseline, at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Visual Acuity of 73 Letters or More in the Study Eye at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Average Visual Acuity Change From Month 3 to Month 4 Through Month 24 in the Study Eye | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Month 3 to Month 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Average Visual Acuity Change From Baseline to Month 1 Through Month 12 and 24 in the Study Eye | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Central Sub-Field Thickness (CSFT) and Central Sub-Field Volume (CSFV) of the Study Eye Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Dry Retina in the Study Eye on OCT at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Lesion Size and Morphology Based on Fluorescein Angiography at Month 12 and 24 | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Treatment Patterns Over Time in Both Treatment Arms | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the National Eye Institute Visual Functioning Questionnaire (NEI-VFQ-25) Scores Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Baseline to Month 12 and 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Frequency and Severity of Ocular and Non-ocular Adverse Events Over Time | During the course of the study, the use of optical coherence tomography (OCT)-guided therapy became a standard of care accepted by health authorities and the ophthalmology community in the treatment of neovascular (wet) age-related macular degeneration (nAMD), Novartis decided on 08-Oct-2014 the early termination of the study. Therefore the 12-month cutoff date was not reached and the related analyses were not performed. | Early termination of the study, therefore the 12-month cutoff date was not reached and the related analysis was not performed | Posted | Screening to Month 12 and 24 |
|
Not provided
Not provided
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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 | RBZ 0.5 mg: VA Only (Group I) | RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD) | 30 | 334 | 111 | 334 | ||
| EG001 | RBZ 0.5 mg: VA and/or OCT (Group II) | RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT). | 45 | 336 | 105 | 336 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Choroidal haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Optic ischaemic neuropathy (Fellow untreated eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal artery embolism (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Visual acuity reduced (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic hepatitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Visual acuity tests abnormal (Study eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Malignant neoplasm of ampulla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Mesothelioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Metastases to skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid artery occlusion | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Encephalitis post varicella (Study eye) | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertebrobasilar insufficiency | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast calcifications | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Choroidal neovascularisation (Fellow untreated eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye (Fellow untreated eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye pain (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration (Fellow untreated eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vitreous floaters (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
Use of optical coherence tomography guided therapy in the treatment of neovascular age related macular degeneration became standard of care by HA & Ophth. community during the time this trial was conducted.Novartis terminated this trial.
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 the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| 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
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