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)

Phase 1

• Conditions: Macular Degeneration
• Interventions: Drug: ORA102 and Avastin; Drug: Avastin

• Registration Number: NCT00745511
• Lead Sponsor: Ora Bio Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Study Start: 2009-03
• Status Verified: 2009-06
• Last Update Submitted: 2009-06-07
• Last Update Posted: 2009-06-09
• Primary Completion: 2010-06
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ORA102 and Avastin	-
2	ORA102 and Avastin	-
3	Avastin	-

Primary Outcome Measures

Name	Time	Method
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.	32 weeks

Secondary Outcome Measures

Name	Time	Method
Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32	32 weeks

Trial Locations

Locations (5)

Barzilai Medical Center; 🇮🇱 Ashkelon, Israel

Ziv Medical Center; 🇮🇱 Zefat, Israel

Carmel Medical Center; 🇮🇱 Haifa, Israel

Hadassah Medical center Israel; 🇮🇱 Jerusalem, Israel

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel