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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)

Primary Purpose

Macular Degeneration

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
ORA102 and Avastin
Avastin
Sponsored by
Ora Bio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Barzilai Medical CenterRecruiting
  • Carmel Medical CenterRecruiting
  • Hadassah Medical center IsraelRecruiting
  • Tel-Aviv Sourasky Medical CenterRecruiting
  • Ziv Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2008
Last Updated
June 7, 2009
Sponsor
Ora Bio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00745511
Brief Title
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)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ora Bio Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ORA102 and Avastin
Intervention Description
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32
Time Frame
32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yossi Israeli
Phone
+972-26067006
Email
yos@orabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itay Chovers, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barzilai Medical Center
City
Ashkelon
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical center Israel
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itay Chovers, MD
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Name
Ziv Medical Center
City
Zefat
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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)

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