Clinical trial NCT00745511: Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)
Official title: A Randomized, Multi-Center, Double Blind, 3 Arm, Phase I/II Pilot Study to Evaluate the Safety and Efficacy of Treatment With ORA102 Combined With Avastin (Bevacizumab) Versus Avastin Alone, in Patients With Neovascular Age Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Macular Degeneration
Keywords: AMD
Avastin
ORA102
macular degeneration
neo-vascular age related macular degeneration (AMD)
Lead sponsor: Ora Bio Ltd.
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 96
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is s randomized, multi-center, double blind, 3 arm, phase I/II pilot study to evaluate the safety and efficacy of treatment with ORA102 combined with Avastin (Bevacizumab) versus Avastin alone, in patients with neo-vascular age related macular degeneration (AMD).


Eligibility criteria: Inclusion Criteria:

* Subjects who have provided informed consent, including signing of the informed consent form
* Subject who are able and willing to comply with the study protocol
* Subject must have best corrected visual acuity ETDRS between 20/40 to 20/320 in the study eye
* Subjects whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy
* Women must be post-menopausal 1 year or surgically sterilized. If not, negative serum pregnancy test required within 14 days of randomization

Exclusion Criteria:

* Pregnant or lactating women
* Patients with severe myocardial disease or coronary occlusion
* Patients with severe personality disorder, suicidal risk or psychosis
* Patients with previous history of CVA
* Evidence for liver dysfunction - bilirubin level more than twice than upper limit of the normal value OR ALT/AST\>1.5x upper limit of normal value
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contra-indicates the use of the investigational drugs or puts the patients in high risk for treatment related complications

Primary outcomes:
measure: The incidence and severity of ocular adverse events, including retinal detachment, increase in IOP, cataract, tearing of the retina, decrease in vision, RPE atrophy, and vitreous hemorrhage, will be evaluated.
timeFrame: 32 weeks
Secondary outcomes:
measure: Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical center Israel
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Itay Chovers, MD
role: PRINCIPAL_INVESTIGATOR
References: