Retinal IschemiaPhase 1/2NCT00841373
Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease
A Phase 1/2 study testing Panretinal Photocoagulation and Panretinal Photocoagulation and intravitreal injection of ranibizumab in people with Retinal Ischemia, run by Southern New England Retina Associates at 1 site in United States.
Trial summary
The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Ischemia
- What is being tested?
- Panretinal Photocoagulation and Panretinal Photocoagulation and intravitreal injection of ranibizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects must meet the following criteria to be eligible for study entry:
- Signed informed consent and authorization of use and disclosure of protected health information
- Age = 18 years
- Presence of iris neovascularization and or angle neovascularization due to any retinal ischemic disease that is new onset or noted to progress recently on the slit lamp examination or gonioscopy
- Best corrected visual acuity in the study eye 20/20 (Snellen equivalent using EDTRS protocol at 4 meters) to light perception. Only one eye will be enrolled in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be better than no light perception
- Patient is able and willing to return for all scheduled visits
Who cannot join
- Use of intraocular or periocular injection of steroids (for, example triamcinolone) in the study eye within 3 months of the study
- Use of intraocular injection of anti-angiogenic drugs in the study eye and or participation in a clinical trial using an antiangiogenic treatment within 45 days from the enrollment in the study.
- Acute endophthalmitis within 1 month.
- Recent rhegmatogenous retinal detachment or macular hole surgery within last 2 months
- Uncontrolled uveitis in the last month.
- Treatment with PRP within 2 weeks of the study enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern New England Retina Associates
Providence, Rhode Island, 02904
About this study
The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab.
Read the detailed description
A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addition to treatment with PRP using the incidence and severity of adverse events identified by subjenc reporting vital signs, and ocular examition.
B.To assess the proportion of patients who fail to experience regression of iris and angle neovascularization documented by the clinical examination, iris florescein angiography and gonioscopic evaluation.
- Conditions
- Retinal Ischemia
- Being tested
- Panretinal Photocoagulation, Panretinal Photocoagulation and intravitreal injection of ranibizumab
- Keywords
- Retinal ischemia: Iris/Angle Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal PhotocoagulationProcedure or surgery
Panretinal Photocoagulation treatment
Panretinal Photocoagulation and intravitreal injection of ranibizumabProcedure or surgery
Also called laser and Lucentis
Panretinal photocoagulation and ranibizumab
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Panretinal Photocoagulation Receives: Procedure: Panretinal Photocoagulation |
| 2 | Active comparator | Ranibizumab Supplementing Panretinal Laser Photocoagulation Receives: Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.
Measured: 1 to 12 months
The proportion of patients who fail to maintain regression of iris and angle neovascularization documented by the clinical examination iris fluorescein angiography and gonioscopic evaluation.
Measured: 1 to 12 months
Secondary outcomes (7)
The mean change in best corrected visual acuity score
Measured: 1 to 12 months
The percentage/number of patients that experience vision loss of 30 letters or less
Measured: 1 to 12 months
The percentage number of patients that experience vision improvement of more than 15 letters
Measured: 1 to 12 months
The percentage/number of patients whose vision progressed to no light perception
Measured: 1 to 12 months
The mean change in macular thickness on OCT
Measured: 1 to 12 months
The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision
Measured: 1 to 12 months
The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure
Measured: 1 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJul 2007
- Primary completionJan 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal IschemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern New England Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Mary Savell, Southern New England Retina Associates
- Investigators
- Magdalena G Krzystolik, MD, Principal investigator, Southern New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841373
- Sponsor's protocol ID
- 100,611
- Status last verified
- Nov 2014
- First submitted
- 10 Feb 2009
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab Supplementing Panretinal Photocoagulation as Treatment for Iris/Angle Neovascularization in Retinal Ischemic Disease
- ClinicalTrials.gov ID
- NCT00841373
- Acronym / sponsor ID
- 100,611
- Conditions
- Retinal Ischemia
- Keywords
- Retinal ischemia: Iris/Angle Neovascularization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Southern New England Retina AssociatesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Feb 2009 (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.
The object of the study is to compare treatment of iris/angle neovascularization with panretinal photocoagulation (laser) to treatment with panretinal photocoagulation and an anti-angiogenic drug: ranibizumab.
Detailed description
A.To obtain preliminary data on the safety and tolerability of ranibizumab (0.5 mg)in patients with new or progressive neovascularization of the iris or angle due to retinal ischemic diseases in addition to treatment with PRP using the incidence and severity of adverse events identified by subjenc reporting vital signs, and ocular examition.
B.To assess the proportion of patients who fail to experience regression of iris and angle neovascularization documented by the clinical examination, iris florescein angiography and gonioscopic evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Panretinal PhotocoagulationPanretinal Photocoagulation |
| 2 | Active comparator | Procedure: Panretinal Photocoagulation and intravitreal injection of ranibizumabRanibizumab Supplementing Panretinal Laser Photocoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age = 18 years
- Presence of iris neovascularization and or angle neovascularization due to any retinal ischemic disease that is new onset or noted to progress recently on the slit lamp examination or gonioscopy
- Best corrected visual acuity in the study eye 20/20 (Snellen equivalent using EDTRS protocol at 4 meters) to light perception. Only one eye will be enrolled in the study. If both eyes are eligible, the investigator will select the eye to be enrolled. Visual acuity in the non-study eye must be better than no light perception
- Patient is able and willing to return for all scheduled visits
Key exclusion criteria (6 listed)
- Use of intraocular or periocular injection of steroids (for, example triamcinolone) in the study eye within 3 months of the study
- Use of intraocular injection of anti-angiogenic drugs in the study eye and or participation in a clinical trial using an antiangiogenic treatment within 45 days from the enrollment in the study.
- Acute endophthalmitis within 1 month.
- Recent rhegmatogenous retinal detachment or macular hole surgery within last 2 months
- Uncontrolled uveitis in the last month.
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 |
|---|---|---|
| Panretinal PhotocoagulationPanretinal Photocoagulation treatment | Procedure or surgery | 1 |
| Panretinal Photocoagulation and intravitreal injection of ranibizumabAlso: laser and LucentisPanretinal photocoagulation and ranibizumab | Procedure or surgery | 2 |
Primary outcome
The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam.
Time frame: 1 to 12 months
The proportion of patients who fail to maintain regression of iris and angle neovascularization documented by the clinical examination iris fluorescein angiography and gonioscopic evaluation.
Time frame: 1 to 12 months
7 secondary outcomes
The mean change in best corrected visual acuity score
Time frame: 1 to 12 months
The percentage/number of patients that experience vision loss of 30 letters or less
Time frame: 1 to 12 months
The percentage number of patients that experience vision improvement of more than 15 letters
Time frame: 1 to 12 months
The percentage/number of patients whose vision progressed to no light perception
Time frame: 1 to 12 months
The mean change in macular thickness on OCT
Time frame: 1 to 12 months
The percentage/number of eyes that will require surgical intervention to maintain the intraocular pressure or useful vision
Time frame: 1 to 12 months
The percentage/ number of eyes that will require anti-glaucoma medications to control intraocular pressure
Time frame: 1 to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
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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.
Magdalena G Krzystolik, MD principal investigator
Southern New England Retina Associates
1 site 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 Panretinal Photocoagulation and Panretinal Photocoagulation and intravitreal injection of ranibizumab in people with Retinal Ischemia, run by Southern New England Retina Associates at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events identified by subject reporting, vital signs, and ocular exam. (time frame: 1 to 12 months). The study lists 2 primary outcomes in all. 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 19 Nov 2014.