NCT00745511

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

June 9, 2009

Status Verified

June 1, 2009

Enrollment Period

1.3 years

First QC Date

September 2, 2008

Last Update Submit

June 7, 2009

Conditions

Macular Degeneration

Keywords

AMDAvastinORA102macular degenerationneo-vascular age related macular degeneration (AMD)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32

    32 weeks

Study Arms (3)

1

ACTIVE COMPARATOR
Drug: ORA102 and Avastin

2

ACTIVE COMPARATOR
Drug: ORA102 and Avastin

3

PLACEBO COMPARATOR
Drug: Avastin

Interventions

ORA102 and AvastinDRUG

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

12
AvastinDRUG

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

3

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Barzilai Medical Center

Ashkelon, Israel

RECRUITING

Carmel Medical Center

Haifa, Israel

RECRUITING

Hadassah Medical center Israel

Jerusalem, Israel

RECRUITING

Ziv Medical Center

Safed, Israel

RECRUITING

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Itay Chovers, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yossi Israeli

CONTACT

+972-26067006yos@orabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

March 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

June 9, 2009

Record last verified: 2009-06

Locations

IL(5)