Macular Edema (ME) Clinical Trial
Official title:
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravtitreal Injections in Patients With Visual Impairment Due to VEGF-driven Macular Edema
| Verified date | November 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | European Union: European Medicines Agency |
| Study type | Interventional |
To evaluate the efficacy and safety of 0.5 mg in adult patients with visual impairment due to macular edema (ME).
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | September 2015 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of active ME secondary to any causes; - BCVA must be between = 24 and = 83 letters; - Visual loss should be mainly due to the presence of any eligible types of ME. Exclusion Criteria: - Women of child-bearing potential, - Active malignancies; - History of stroke less than 6 months prior to screening; - Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME; - Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation; - Any type of advanced, severe or unstable ocular disease or its reatment; - ME with a high likelihood of spontaneous resolution. Other protocol-defined inclusion/exclusion criteria may apply. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Adelaide | South Australia |
| Australia | Novartis Investigative Site | Hobart | Tasmania |
| Australia | Novartis Investigative Site | South Launceston | Tasmania |
| Australia | Novartis Investigative Site | Sydney | New South Wales |
| Australia | Novartis Investigative Site | Westmead | New South Wales |
| Belgium | Novartis Investigative Site | Leuven | |
| Canada | Novartis Investigative Site | Halifax | Nova Scotia |
| Czech Republic | Novartis Investigative Site | Plzen | |
| Czech Republic | Novartis Investigative Site | Praha 10 | |
| France | Novartis Investigative Site | Bordeaux Cedex | |
| France | Novartis Investigative Site | Lyon | |
| France | Novartis Investigative Site | Paris cedex 10 | |
| France | Novartis Investigative Site | Saint-Jean | |
| Germany | Novartis Investigative Site | Duesseldorf | |
| Germany | Novartis Investigative Site | Freiburg i. Br | |
| Germany | Novartis Investigative Site | Leipzig | |
| Germany | Novartis Investigative Site | Regensburg | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Budapest | |
| Hungary | Novartis Investigative Site | Debrecen | |
| Hungary | Novartis Investigative Site | Szeged | |
| Israel | Novartis Investigative Site | Jerusalem | |
| Israel | Novartis Investigative Site | Kfar-Sava | |
| 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 | Genova | GE |
| Italy | Novartis Investigative Site | Milano | MI |
| Italy | Novartis Investigative Site | Pisa | PI |
| Italy | Novartis Investigative Site | Roma | RM |
| Italy | Novartis Investigative Site | Torino | TO |
| Korea, Republic of | Novartis Investigative Site | Busan | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Korea, Republic of | Novartis Investigative Site | Seoul | Korea |
| Latvia | Novartis Investigative Site | Riga | |
| Netherlands | Novartis Investigative Site | Amsterdam | |
| Netherlands | Novartis Investigative Site | Tilburg | |
| Russian Federation | Novartis Investigative Site | Kazan | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Russian Federation | Novartis Investigative Site | Moscow | |
| Singapore | Novartis Investigative Site | Singapore | |
| Slovakia | Novartis Investigative Site | Banska Bystrica | |
| Slovakia | Novartis Investigative Site | Trencin | |
| Spain | Novartis Investigative Site | Hospitalet de Llobregat | Barcelona |
| Spain | Novartis Investigative Site | Malaga | Andalucia |
| Spain | Novartis Investigative Site | Sant Cugat | Catalunya |
| Spain | Novartis Investigative Site | Valladolid | Castilla y Leon |
| Switzerland | Novartis Investigative Site | Bern | |
| Switzerland | Novartis Investigative Site | Binningen | |
| Switzerland | Novartis Investigative Site | Zuerich | |
| Turkey | Novartis Investigative Site | Ankara | |
| Turkey | Novartis Investigative Site | Kocaeli | |
| United Kingdom | Novartis Investigative Site | Birmingham | |
| United Kingdom | Novartis Investigative Site | Bristol | |
| United Kingdom | Novartis Investigative Site | Frimley | Surrey |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Manchester | |
| United Kingdom | Novartis Investigative Site | Southampton | |
| United Kingdom | Novartis Investigative Site | Sunderland |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Australia, Belgium, Canada, Czech Republic, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Latvia, Netherlands, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Best-corrected visual acuity (BCVA) change from baseline to Month 2 in study eye | The change in BCVA from baseline to Month 2 | Baseline and Month 2 | No |
| Secondary | BCVA change from baseline by visit up to Month 2 in study eye (ranibizumab as compared to sham treatment) | The change in BCVA will be presented by each visit (BSL, Month 1, Month 2) | Baseline, Month 2 | No |
| Secondary | Change in central subfield thickness (CSFT) and central subfield volume (CSFV) in study eye from baseline over time to Month 2 | CSFT and CSFV will be assessed by optical coherence tomography (OCT). | Baseline, Month 2 | No |
| Secondary | Presence of intra-/subretinal fluid in study eye at Month 2 | The presence of intra-/sub-retinal fluid will be assessed by OCT images. | Baseline, Month 2 | No |
| Secondary | Presence of active ME leakage assessed by fluorescein angiography (FA) at Month 2 | The presence of active ME leakage will be assessed by photography imaging (i.e., FA). | Month 2 | No |
| Secondary | Requirement for rescue treatment at Month 1 | Month 1 | No | |
| Secondary | Average BCVA change in study eye from baseline to Month 1 through Month 12 | all monthly BCVA outcomes compared to the BCVA at baseline. | Baseline, Month 1, Month 6, Month 12 | No |
| Secondary | Change from baseline in CSFT and CSFV in study eye by visit | The change in CSFT and CSFV will be assessed monthly by OCT | Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 | No |
| Secondary | Presence of intra-/subretinal fluid in study eye at Month 2, Month 6, and Month 12 compared to Baseline | The presence of intra-/sub-retinal fluid will be assessed by OCT | Baseline, Month 2, Month 6, Month 12 | No |
| Secondary | Presence of active ME leakage in study eye at Month 2, Month 6, and Mon th 12 compared to Baseline | The presence of active ME leakage will be assessed by photographic images (i.e. Fluorescein angiography). | Baseline, Month 2, Month 6, Month 12 | No |
| Secondary | Proportion of patients with = 1, = 5, = 10 and = 15 letters gain or reaching 84 letters, at Month 2, Month 6 and Month 12 | This outcome measure represents the proportion of different levels of BCVA gain. | Month 2, Month 6 , Month 12 | No |
| Secondary | Porportion of patients with > 1, > 5, > 10 and > 15 letters loss at Month 2, Month 6 and Month 12 | This outcome measure represents the proportion of different levels of BCVA loss | Month 2, Month 6, Month 12 | No |
| Secondary | Number of ranibizumab treatments and re-treatments to study eye by Month 2, Month 6, Month 12 | Total number of injections and number of injections given to the study eye by visit | Month 2, Month 6, Month 12 | No |
| Secondary | Type, frequency and severity of ocular and non-ocular adverse events in the study eye up Month 2, up to Month 6 and up to Month 12 | Safety parameters will include reports of both ocular and non-ocular adverse events (AEs). Safety findings resulting from ophthalmic examinations, vital signs, laboratory results if reported as an adverse event (AE) will be presented. | Month 2, Month 6, Month 12 | Yes |