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)

Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00745511
• Other study ID #: OB-DAMD-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 2, 2008
• Last updated: June 7, 2009
• Start date: March 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2009
• Source: Ora Bio Ltd.
• Contact: Yossi Israeli
• Phone: +972-26067006
• Email: yos[@]orabio.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
• Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashkelon
Israel	Carmel Medical Center	Haifa
Israel	Hadassah Medical center Israel	Jerusalem
Israel	Tel-Aviv Sourasky Medical Center	Tel-Aviv
Israel	Ziv Medical Center	Zefat

Sponsors (1)

Lead Sponsor	Collaborator
Ora Bio Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32		32 weeks	No