Macular DegenerationPhase 1/2NCT00745511
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)
A Phase 1/2 study testing ORA102 and Avastin and Avastin in people with Macular Degeneration, run by Ora Bio Ltd. at 5 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- ORA102 and Avastin and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 5 sitesIsrael
- Study dates
- Mar 2009to Jun 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites, 5 recruiting
- Recruiting
Barzilai Medical Center
Ashkelon
- Recruiting
Carmel Medical Center
Haifa
- Recruiting
Hadassah Medical center Israel
Jerusalem
Itay Chovers, MD
- Recruiting
Ziv Medical Center
Safed
- Recruiting
Tel-Aviv Sourasky Medical Center
Tel Aviv
About this study
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)
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).
- Conditions
- Macular Degeneration
- Being tested
- ORA102 and Avastin, Avastin
- Keywords
- AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORA102 and AvastinDrug
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102
AvastinDrug
treatment with intravitreal injections of Avastin 1.25mg (0.05ml)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: ORA102 and Avastin |
| 2 | Active comparator | Not described Receives: Drug: ORA102 and Avastin |
| 3 | Placebo comparator | Not described Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 32 weeks
Secondary outcomes (1)
Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32
Measured: 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionJun 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ora Bio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Itay Chovers, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745511
- Sponsor's protocol ID
- OB-DAMD-01
- Status last verified
- Jun 2009
- First submitted
- 2 Sep 2008
- Last updated
- 9 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00745511
- Acronym / sponsor ID
- OB-DAMD-01
- Conditions
- Macular Degeneration
- Keywords
- AMD, Avastin, ORA102, macular degeneration, neo-vascular age related macular degeneration (AMD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Ora Bio Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 3 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ORA102 and Avastin |
| 2 | Active comparator | Drug: ORA102 and Avastin |
| 3 | Placebo comparator | Drug: Avastin |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ORA102 and Avastintreatment with intravitreal injections of Avastin 1.25mg (0.05ml)and ORA102 | Drug | 1, 2 |
| Avastintreatment with intravitreal injections of Avastin 1.25mg (0.05ml) | Drug | 3 |
Primary outcome
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
1 secondary outcome
Central Retinal thickness and presence of intra/sub-retinal fluid observed by OCT at week 32
Time frame: 32 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itay Chovers, MD principal investigator
Hadassah Medical Organization
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ORA102 and Avastin and Avastin in people with Macular Degeneration, run by Ora Bio Ltd. at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yossi Israeli (+972-26067006, yos@orabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2009.