The Efficacy of Oral Everolimus in Patients With Neovascular Age-Related Macular Degeneration - Full Text View

Sponsor:	Novartis
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

Condition	Intervention	Phase
Choroidal Neo-Vascular Age-Onset Macular Degeneration Age-Related Macular Degeneration	Drug: RAD001 Drug: Lucentis Drug: RAD001 in combination with Lucentis	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Everolimus Ranibizumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Reduction of central retinal thickness, as measured by optical coherence tomography Measure: Optical Coherence Tomography ( OCT) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Increase in visual acuity Measure: ETDRS Visual acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	63
Study Start Date:	February 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Everolimus (RAD001): Experimental	Drug: RAD001
Lucentis (Ranibizumab): Active Comparator	Drug: Lucentis
RAD001 plus Lucentis Experimental in combination with active comparator	Drug: RAD001 in combination with Lucentis

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with neovascular AMD
Best corrected visual acuity ( BCVA) of 20/40 or worse in study eye

Exclusion Criteria:

Any concurrent ocular condition in the study eye that may result in substantial change in vision during the study
Recent use of other VEGF inhibitors or Intravitreal injections in the study eye
Uncontrolled medical conditions such as cancer, angina, diabetes, viral or fungal infections, impaired lung function, history of stroke

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857259

Contacts

Contact: Novartis Pharmaceuticals Studies with non-US sites:

+41-61-324-1111

Locations

United Kingdom
King's College Hospital NHS Foundation Trust	Recruiting
London, United Kingdom
Contact 044 208 9249761
Bristol Eye Hospital	Recruiting
Bristol, United Kingdom
Contact 44 0117 9284770
New Cross Hospital-Wolverhampton	Recruiting
Wolverhampton, United Kingdom
Contact 44 01902 645023

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CRAD001A2203, EudraCT number: 2008-003550-15
Study First Received:	March 4, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00857259 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Novartis:

AMD
macular degeneration
Everolimus
Lucentis

Ranibizumab
Choroidal Neo-Vascular (CNV) age-onset macular degeneration
Age-related Macular Degeneration (AMD)

Additional relevant MeSH terms:

Everolimus
Immunologic Factors
Eye Diseases
Physiological Effects of Drugs
Retinal Degeneration

Macular Degeneration
Immunosuppressive Agents
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on February 08, 2010