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)

June 7, 2009 updated by: Ora Bio Ltd.

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)

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

96

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yossi Israeli
  • Phone Number: +972-26067006
  • Email: yos@orabio.com

Study Locations

  • Israel
      • Ashkelon, Israel
        • Recruiting
        • Barzilai Medical Center
      • Haifa, Israel
        • Recruiting
        • Carmel Medical Center
      • Jerusalem, Israel
        • Recruiting
        • Hadassah Medical center Israel
        • Principal Investigator:
          • Itay Chovers, MD
      • Tel-Aviv, Israel
        • Recruiting
        • Tel-Aviv Sourasky Medical Center
      • Zefat, Israel
        • Recruiting
        • Ziv Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Drug: ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
Active Comparator: 1
Drug: ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
Placebo Comparator: 3
Drug: Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 32 weeks
32 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ora Bio Ltd.

Investigators

  • Principal Investigator: Itay Chovers, MD, Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

June 9, 2009

Last Update Submitted That Met QC Criteria

June 7, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB-DAMD-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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