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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)

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ClinicalTrials.gov Identifier: NCT00745511
Recruitment Status : Unknown
Verified June 2009 by Ora Bio Ltd..
Recruitment status was:  Recruiting
First Posted : September 3, 2008
Last Update Posted : June 9, 2009
Sponsor:
Information provided by:
Ora Bio Ltd.

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: ORA102 and Avastin Drug: Avastin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : March 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
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)




Primary Outcome Measures :
  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. [ Time Frame: 32 weeks ]

Secondary Outcome Measures :
  1. Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32 [ Time Frame: 32 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yossi israeli, Ora Bio Ltd
ClinicalTrials.gov Identifier: NCT00745511     History of Changes
Other Study ID Numbers: OB-DAMD-01
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: June 9, 2009
Last Verified: June 2009

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
Growth Inhibitors
Antineoplastic Agents