Diabetic RetinopathyPhase 2NCT01476449
Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema
A Phase 2 study testing Ranibizumab in people with Diabetic Retinopathy and Macular Edema, run by Retina Vitreous Associates of Florida at 2 sites in United States.
Trial summary
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Sep 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Patient related considerations
- Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
- Disease related considerations:
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- Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
- Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
- Central foveal thickness on SD-OCT of >300um
Who cannot join
- 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
- Foveal ischemia on IVFA
- Intraocular surgery less than 6 months ago
- Epiretinal membrane of clinical significance
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- Prior vitrectomy
- Uncontrolled glaucoma
- Macular or peripheral laser within 90 Days from Day 0 injection
- Intravitreal steroid injection within 90 days from Day 0 injection
- Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Vitreous Associates of Florida
Clearwater, Florida, 33756
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
About this study
Official title: Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
Read the detailed description
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Diabetic Macular Edema, Diabetic Retinal Swelling, DIabetic Eye Disease
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
RanibizumabDrug
Also called Lucentis
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
| Study group | Role | What they receive |
|---|---|---|
| Monthly Ranibizumab | Active comparator | Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. Receives: Drug: Ranibizumab |
| Treat and Extend Ranibizumab | Experimental | Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Measured: Baseline through 24 months
Secondary outcomes (4)
Mean Number of Injections.
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Measured: 24 months
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Measured: 24 months
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Measured: 24 months
Percentage of Patients Anatomically "Dry."
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Vitreous Associates of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- David Eichenbaum, MD, Principal investigator, Retina Vitreous Associates of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476449
- Sponsor's protocol ID
- 1127228
- Status last verified
- Apr 2019
- First submitted
- 13 Nov 2011
- Last updated
- 17 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01476449
- Acronym / sponsor ID
- 1127228
- Conditions
- Diabetic Retinopathy, Macular Edema
- Keywords
- Diabetic Macular Edema, Diabetic Retinal Swelling, DIabetic Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Retina Vitreous Associates of FloridaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Nov 2011
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.
Detailed description
This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monthly Ranibizumab | Active comparator | Drug: RanibizumabPatients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study. |
| Treat and Extend Ranibizumab | Experimental | Drug: RanibizumabPatients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years
- Patient related considerations
- Phakic or pseudophakic patients with a known history of diabetes will be eligible.
- Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
Key exclusion criteria (11 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
- Foveal ischemia on IVFA
- Intraocular surgery less than 6 months ago
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 |
|---|---|---|
| RanibizumabAlso: LucentisPars plana injection of ranibizumab 0.5mg into the vitreous cavity. | Drug | Monthly Ranibizumab |
| RanibizumabAlso: LucentisPars plana injection of ranibizumab 0.5mg into the vitreous cavity. | Drug | Treat and Extend Ranibizumab |
Primary outcome
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
Time frame: Baseline through 24 months
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
4 secondary outcomes
Mean Number of Injections.
Time frame: 24 months
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Time frame: 24 months
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
Time frame: 24 months
Percentage of Patients Anatomically "Dry."
Time frame: 24 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Eichenbaum, MD principal investigator
Retina Vitreous Associates of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab in people with Diabetic Retinopathy and Macular Edema, run by Retina Vitreous Associates of Florida at 2 sites 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 9 inclusion and 11 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 17 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. (time frame: Baseline through 24 months). 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 17 May 2019.