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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Ora Bio Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ora Bio Ltd.
ClinicalTrials.gov Identifier:
NCT00745511
First received: September 2, 2008
Last updated: June 7, 2009
Last verified: June 2009
  Purpose

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).


Condition Intervention Phase
Macular Degeneration
Drug: ORA102 and Avastin
Drug: Avastin
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Ora Bio Ltd.:

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. [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32 [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: March 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ORA102 and Avastin
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
Active Comparator: 2 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)

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745511

Contacts
Contact: Yossi Israeli +972-26067006 yos@orabio.com

Locations
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel
Carmel Medical Center Recruiting
Haifa, Israel
Hadassah Medical center Israel Recruiting
Jerusalem, Israel
Principal Investigator: Itay Chovers, MD         
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Ziv Medical Center Recruiting
Zefat, Israel
Sponsors and Collaborators
Ora Bio Ltd.
Investigators
Principal Investigator: Itay Chovers, MD Hadassah Medical center
  More Information

No publications provided

Responsible Party: Yossi israeli, Ora Bio Ltd
ClinicalTrials.gov Identifier: NCT00745511     History of Changes
Other Study ID Numbers: OB-DAMD-01
Study First Received: September 2, 2008
Last Updated: June 7, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Ora Bio Ltd.:
AMD
Avastin
ORA102
macular degeneration
neo-vascular age related macular degeneration (AMD)

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014