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)

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)

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745511

Enrollment

Registered

2008-09-03

Start date

2009-03-31

Completion date

2010-06-30

Last updated

2009-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)

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).

Interventions

DRUGORA102 and Avastin

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

DRUGAvastin

treatment with intravitreal injections of Avastin 1.25mg (0.05ml)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Israel

Contacts

Primary ContactYossi Israeli

yos@orabio.com+972-26067006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026