|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Novartis Pharmaceuticals |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00857259 |
Purpose
The study will assess the safety and efficacy of Everolimus (RAD001) alone or in combination with Lucentis in patients with neo-vascular age related macular degeneration (AMD)
| Condition | Intervention | Phase |
|---|---|---|
|
Choroidal Neo-Vascular Age-onset Macular Degeneration Age-related Macular Degeneration |
Drug: Everolimus Drug: Ranibizumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-masked, Parallel Group Study to Assess the Efficacy of Oral Everolimus, Either Alone or Added to Lucentis, in Patients With Neovascular Age-related Macular Degeneration |
| Enrollment: | 16 |
| Study Start Date: | February 2009 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Everolimus 5 mg
5 mg orally once daily plus sham ocular injection on Day 1 (Baseline) until Day 28
|
Drug: Everolimus
5 mg oral tablet
|
|
Active Comparator: Ranibizumab 0.5 mg
Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
|
Drug: Ranibizumab
0.5 mg administered by intravitreal injection
|
|
Active Comparator: Oral Everolimus (5mg) and Ranibizumab (0.5mg)
Everolimus orally 5 mg once daily plus Ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
|
Drug: Everolimus
5 mg oral tablet
Drug: Ranibizumab
0.5 mg administered by intravitreal injection
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| United States, California | |
| Retina-Vitreous Associates Medical Group | |
| Beverley Hills, California, United States, 90211 | |
| Retinal Consultants Medical Group, Inc. | |
| Sacramento, California, United States | |
| United States, Colorado | |
| Porter Adventist Hospital, Diagnostic Eye Laboratory | |
| Denver, Colorado, United States, 80210 | |
| United States, Missouri | |
| Discover Vision Center | |
| Independence, Missouri, United States, 64055 | |
| United Kingdom | |
| Novartis Investigative Site | |
| Bristol, United Kingdom | |
| Novartis Investigative Site | |
| Frimley, United Kingdom | |
| Novartis Investigative Site | |
| Liverpool, United Kingdom | |
| Novartis Investigative Site | |
| London, United Kingdom | |
| Novartis Investigative Site | |
| Oxford, United Kingdom | |
| Novartis Investigative site | |
| Portsmouth, United Kingdom | |
| Novartis Investigative Site | |
| Southampton, United Kingdom | |
| Novartis Investigator Site | |
| Wolverhampton, United Kingdom | |
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
| Responsible Party: | External Affairs, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00857259 History of Changes |
| Other Study ID Numbers: | CRAD001A2203, EudraCT number: 2008-003550-15 |
| Study First Received: | March 4, 2009 |
| Results First Received: | July 22, 2011 |
| Last Updated: | July 22, 2011 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
|
AMD macular degeneration Everolimus Lucentis |
Ranibizumab Choroidal Neo-Vascular (CNV) age-onset macular degeneration Age-related Macular Degeneration (AMD) |
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Everolimus Sirolimus Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Antifungal Agents Anti-Infective Agents Anti-Bacterial Agents |