Age-related Macular Degeneration Clinical Trial
— TRENDOfficial title:
A 12-month, Phase IIIb, Randomized, Visual Acuity Assessor-masked, Multicenter Study Assessing the Efficacy and Safety of Ranibizumab 0.5mg in Treat and Extend Regimen Compared to Monthly Regimen, in Patients With Neovascular AMD
This study is designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
Status | Completed |
Enrollment | 649 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients, =50 years of age with signed informed consent before study procedures - Visual impairment predominantly due to nAMD. - Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography - Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT - BCVA score must be = 78 and = 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320) Exclusion Criteria: - Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk. - Stroke or myocardial infarction within 3 months prior to Screening. - Any active periocular or ocular infection or inflammation in both eyes. - Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity. - Presence of amblyopia or amaurosis in the fellow eye. - History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye. - History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening. - Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Belgium | Novartis Investigative Site | Antwerpen | |
Belgium | Novartis Investigative Site | Ottignies | |
Belgium | Novartis Investigative Site | Zottegem | |
Chile | Novartis Investigative Site | Santiago | |
Croatia | Novartis Investigative Site | Zagreb | |
Denmark | Novartis Investigative Site | Glostrup | |
Denmark | Novartis Investigative Site | Roskilde | |
Egypt | Novartis Investigative Site | Cairo | Abbassia |
Egypt | Novartis Investigative Site | Cairo | |
Germany | Novartis Investigative Site | Ahaus | |
Germany | Novartis Investigative Site | Augsburg | |
Germany | Novartis Investigative Site | Chemnitz | |
Germany | Novartis Investigative Site | Darmstadt | |
Germany | Novartis Investigative Site | Göttingen | |
Germany | Novartis Investigative Site | Hannover | |
Germany | Novartis Investigative Site | Karlsruhe | |
Germany | Novartis Investigative Site | Koeln | |
Germany | Novartis Investigative Site | Leipzig | |
Germany | Novartis Investigative Site | Ludwigshafen | |
Germany | Novartis Investigative Site | Magdeburg | |
Germany | Novartis Investigative Site | Muenster | |
Germany | Novartis Investigative Site | Muenster | |
Germany | Novartis Investigative Site | Siegburg | |
Germany | Novartis Investigative Site | Stuttgart | |
Germany | Novartis Investigative Site | Sulzbach | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Budapest | |
Hungary | Novartis Investigative Site | Debrecen | |
Hungary | Novartis Investigative Site | Pécs | |
Hungary | Novartis Investigative Site | Szeged | |
Hungary | Novartis Investigative Site | Zalaegerszeg | |
India | Novartis Investigative Site | Bangalore | Karnataka |
India | Novartis Investigative Site | Chennai | Tamil Nadu |
India | Novartis Investigative Site | Vanchiyoor | Thiruvanantapuram |
Israel | Novartis Investigative Site | Haifa | |
Israel | Novartis Investigative Site | Jerusalem | |
Israel | Novartis Investigative Site | Petach Tikva | |
Israel | Novartis Investigative Site | Rehovot | |
Israel | Novartis Investigative Site | Tel-Aviv | |
Italy | Novartis Investigative Site | Firenze | FI |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Milano | MI |
Italy | Novartis Investigative Site | Padova | PD |
Italy | Novartis Investigative Site | Pisa | PI |
Italy | Novartis Investigative Site | Roma | RM |
Italy | Novartis Investigative Site | Sassari | SS |
Italy | Novartis Investigative Site | Udine | UD |
Korea, Republic of | Novartis Investigative Site | Busan | |
Korea, Republic of | Novartis Investigative Site | Seongnam | Gyeonggi |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
Portugal | Novartis Investigative Site | Coimbra | |
Portugal | Novartis Investigative Site | Coimbra | |
Portugal | Novartis Investigative Site | Lisboa | |
Portugal | Novartis Investigative Site | Porto | |
Portugal | Novartis Investigative Site | Vila Franca de Xira | |
Russian Federation | Novartis Investigative Site | Kazan | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Moscow | |
Russian Federation | Novartis Investigative Site | Novosibirsk | |
Russian Federation | Novartis Investigative Site | Samara | |
Slovakia | Novartis Investigative Site | Banska Bystrica | |
Slovakia | Novartis Investigative Site | Bratislava | |
Slovakia | Novartis Investigative Site | Nove Zamky | |
Slovakia | Novartis Investigative Site | Poprad | |
Slovakia | Novartis Investigative Site | Zilina | |
Slovenia | Novartis Investigative Site | Ljubljana | |
Spain | Novartis Investigative Site | Barcelona | Cataluña |
Spain | Novartis Investigative Site | Barcelona | |
Spain | Novartis Investigative Site | Oviedo | Asturias |
Spain | Novartis Investigative Site | Sant Cugat | Catalunya |
Spain | Novartis Investigative Site | Valladolid | Castilla y Leon |
Spain | Novartis Investigative Site | Zaragoza | |
Switzerland | Novartis Investigative Site | Bern | |
Switzerland | Novartis Investigative Site | Bern | |
Switzerland | Novartis Investigative Site | Lausanne | |
Switzerland | Novartis Investigative Site | Zuerich | |
Turkey | Novartis Investigative Site | Ankara | |
Turkey | Novartis Investigative Site | Ankara | |
United Kingdom | Novartis Investigative Site | Belfast | |
United Kingdom | Novartis Investigative Site | Bristol | |
United Kingdom | Novartis Investigative Site | Frimley | Surrey |
United Kingdom | Novartis Investigative Site | Guildford, Surrey | |
United Kingdom | Novartis Investigative Site | London | |
United Kingdom | Novartis Investigative Site | Manchester | |
United Kingdom | Novartis Investigative Site | Sunderland | |
United Kingdom | Novartis Investigative Site | Uxbridge | London |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
Belgium, Chile, Croatia, Denmark, Egypt, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Portugal, Russian Federation, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | BCVA change; by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts | To demonstrate that the ranibizumab Treat and Extend regimen is non-inferior to ranibizumab monthly regimen in patients with nAMD as assessed by the change in best corrected visual acuity (BCVA) from baseline to Month 12 | 12 months | No |
Secondary | Change in BCVA score from baseline to month 12 | To evaluate the change in BCVA from baseline over time up to Month 12 by measuring BCVA score at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts | Baseline to Month 12 | No |
Secondary | Number of visits scheduled | The number of visits scheduled according to the treat and extend regimen after treatment initiation | From Month1 to Month 11 | No |
Secondary | Percentage of patients with Best Corrected Visual Acuity (BCVA) improvements =1, =5, =10, =15, and =30 letters by visit | Evaluate the occurrence of BCVA improvements of =1, =5, =10, =15, and =30 letters from baseline, over time up to Month 12. Measurements taken at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts | 12 Months | No |
Secondary | Percentage of patients with Best Corrected Visual Acuity (BCVA) loss >=73 letters by visit | Evaluate the occurrence of absolute BCVA =73 letters (20/40 Snellen equivalent) over time up to Month 12. | 12 Months | No |
Secondary | Percentage of patients with Best Corrected Visual Acuity (BCVA) loss <5, <10, and <15 letters by visit | Evaluate the occurrence of BCVA losses of <5, <10 and <15 letters from baseline, over time up to Month 12 | 12 Months | No |
Secondary | BCVA score measured at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts | Evaluate the time course of mean BCVA from baseline up to Month 12 | 12 Months | Yes |
Secondary | Average change in BCVA from Baseliine to Month 12 | BCVA score measured at 4 meters distance using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts | Baseline, 12 months | No |
Secondary | Period (time) between injections | To assess treatment frequency and average dosing interval | 12 Months | No |
Secondary | Presence of the disease activity | To evaluate the occurrence of a fluid free macula (e.g., no intra-retinal and/or sub-retinal fluid as measured on spectral domain OCT (SD-OCT) over time up to Month 12 | 12 Months | No |
Secondary | Change from baseline in central retinal thickness of the study eye over time | To evaluate the change in central subfield retinal thickness (CSFT) collected by SD-OCT, as evaluated by the Central Reading Center (CRC) from baseline, over time up to Month 12 | 12 Months | No |
Secondary | Percentage of patients with Choroidal Neovascularization (CNV) leakage in the study eye | To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. | 12 Months | No |
Secondary | Quality of Life | To assess the impact on patient functioning and quality of life supported by ranibizumab 0.5 as assessed by the NEI-VFQ-25 | 12 Months | No |
Secondary | Number of participants with Adverse Events as a measure of Safety and Tolerability | 12 Months | Yes |
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