Radiation RetinopathyPhase 1NCT01334879
High Dose Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
A Phase 1 study testing ranibizumab 2.0 mg in people with Radiation Retinopathy, run by The New York Eye Cancer Center at 1 site in United States.
Trial summary
This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Radiation Retinopathy
- What is being tested?
- ranibizumab 2.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible if the following criteria are met:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- History of a clinical diagnosis of radiation retinopathy
- Subjects who are at least 3 months and no more than 10 years from radiation therapy
- History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc
- ETDRS best corrected visual acuity of 20/400 or better in the study eye
- Ability to return for all study visits
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Subjects who have undergone intraocular surgery within last 60 days.
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- Subjects who have had intravitreal anti-VEGF treatment within 30 days.
- Subjects who have had intravitreal triamcinolone acetonide within 4 months.
- Subjects who have had laser within 60 days.
- Inability to obtain photographs to document CNV (including difficulty with venous access).
- Subject with known adverse reaction to fluorescein dye.
- Subject has a history of any medical condition which would preclude scheduled visits or completion of study.
- Aphakia or absence of the posterior capsule in the study eye. Previous violation of the posterior capsule in the study eye is also excluded unless as a result of yttrium aluminum garnet (YAG) posterior capsulotomy in association with posterior chamber lens implantation..
- History of glaucoma filtering surgery in the study eye.
- Concurrent use of more than two therapies for glaucoma.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure >30 mm Hg despite treatment with anti-glaucoma medication)
- Inability to comply with study or follow-up procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye Cancer Center
New York, New York, 10065
About this study
Official title: High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
This study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
Read the detailed description
This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.
- Conditions
- Radiation Retinopathy
- Being tested
- ranibizumab 2.0 mg
- Keywords
- radiation, retinopathy, anti-VEGF, eye
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab 2.0 mgDrug
Also called Lucentis
Intravitreal ranibizumab (2.0 mg)
| Study group | Role | What they receive |
|---|---|---|
| With Loading Doses | Active comparator | 5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections) Receives: Drug: ranibizumab 2.0 mg |
| Physician Discretion | Active comparator | 5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study. Receives: Drug: ranibizumab 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (allergy, infection, or change in vital signs)
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
Measured: Baseline, at day 7, then monthly
Secondary outcomes (4)
Number of participants with changes in central foveal thickness
This secondary outcome measure will evaluate the effect of ranibizumab in both groups (arms) on Regression of radiation retinopathy as measured by mean change in central retinal thickness as measured on optical coherence tomography (OCT) compared to baseline
Measured: Monthly, Report at Month 12
Number of participants with changes in visual acuity
Each month each subject will be tested for best corrected visual acuity as compared to baseline.
Measured: Monthly, Report at Month 12
Number of injections each group (arm) has received
Each group (arm) will be assessed for the number of monthyl injections received through Month 12.
Measured: Monthly, Report at Month 12
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
Evaluation of both arms on qualitative change in exudates, retinal hemorrhage, microaneurym and neovascularization) as seen on ophthalmoscopy/color photography and fluorescein angiography compared to baseline.
Measured: Monthly Report at Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation RetinopathyStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Paul T. Finger, MD, The New York Eye Cancer Center
- Investigators
- Paul T Finger, MD, Principal investigator, The New York Eye Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334879
- Sponsor's protocol ID
- FVF4981S
- Status last verified
- Sep 2014
- First submitted
- 11 Apr 2011
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose (2.0mg) Intravitreal Ranibizumab for Recalcitrant Radiation Retinopathy
- ClinicalTrials.gov ID
- NCT01334879
- Acronym / sponsor ID
- FVF4981S
- Conditions
- Radiation Retinopathy
- Keywords
- radiation, retinopathy, anti-VEGF, eye
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The New York Eye Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Apr 2011 (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 study investigates the use of a high dose anti-VEGF agent for the treatment of radiation retinopathy in those patients who have recalcitrant disease.
Detailed description
This study is an open-label, Phase I study of intravitreally administered ranibizumab in subjects with radiation retinopathy. This is a single center, non-randomized, active treatment study involving 10 consecutive patients. This study will evaluate the safety and tolerability of a high dose (2.0 mg) intravitreal ranibizumab and its effect on regression of radiation retinopathy and mean change in visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Loading Doses | Active comparator | Drug: ranibizumab 2.0 mg5 patients will receive intravitreal injections every 30 days (+/- 7 days) for the first 4 months and every month thereafter until month 12 (maximum of 12 injections) |
| Physician Discretion | Active comparator | Drug: ranibizumab 2.0 mg5 patients will receive intravitreal ranibizumab every 30 days (+/- 7 days) on as needed basis based on the criteria defined in the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- History of a clinical diagnosis of radiation retinopathy
- Subjects who are at least 3 months and no more than 10 years from radiation therapy
- History of prior treatment for radiation retinopathy with incomplete response (eg. persistent edema, presence of hemorrhage, presence of exudates, etc
Key exclusion criteria (17 listed)
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
- Subject with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Subjects who have undergone intraocular surgery within last 60 days.
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 |
|---|---|---|
| ranibizumab 2.0 mgAlso: LucentisIntravitreal ranibizumab (2.0 mg) | Drug | Physician Discretion, With Loading Doses |
Primary outcome
Number of participants with adverse events (allergy, infection, or change in vital signs)
Time frame: Baseline, at day 7, then monthly
All subjects will be assessed at baseline, at 7 days after first injection, and monthly for adverse events. The primary outcome measures for safety and tolerability are: 1. incidence and severity of ocular adverse events, as identified by eye examination (including best corrected visual acuity testing) and 2. Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
4 secondary outcomes
Number of participants with changes in central foveal thickness
Time frame: Monthly, Report at Month 12
Number of participants with changes in visual acuity
Time frame: Monthly, Report at Month 12
Number of injections each group (arm) has received
Time frame: Monthly, Report at Month 12
Number of participants with qualitative changes in retinopathy on ophthalmoscopy and fluorescein angiography
Time frame: Monthly Report at Month 12
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 2 Oct 2014.
- Dr. Finger's Radiation Retinopathy StudiesLink provided by the sponsor.
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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.
Paul T Finger, MD principal investigator
The New York Eye Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ranibizumab 2.0 mg in people with Radiation Retinopathy, run by The New York Eye Cancer Center 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 8 inclusion and 17 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 2 Oct 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 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.
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?
Number of participants with adverse events (allergy, infection, or change in vital signs) (time frame: Baseline, at day 7, then monthly). 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 2 Oct 2014.