Diabetic Macular EdemaPhase 2NCT01472510
Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
A Phase 2 study testing Ranibizumab in people with Diabetic Macular Edema, run by Vitreo-Retinal Associates, PC at 1 site in United States.
Trial summary
This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic 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
- 1 siteUnited States
- Study dates
- Dec 2011to Jan 2014
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible if the following criteria are met:
- Age > 18 years
- Diagnosis of diabetes mellitus (type 1 or 2)
- Residual edema as determined by mean foveal thickness on Cirrus OCT > 300 microns and leakage seen on FA at baseline
- Clinical evidence of retinal thickening due to macular edema involving the center of the macula, associated with diabetic retinopathy.
- Previous history of at least 4 or more consecutive anti-VEGF intravitreal injections of Pegaptanib sodium or Bevacizumab (consecutive injections administered no more than 6 weeks apart in the last year) for the treatment of diabetic macular edema.
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- Previous history of focal laser and/or intravitreal steroid injection for the treatment of diabetic macular edema.
- BCVA of 20/32-20/400 (ETDRS)
- Media clarity, pupillary dilation and patient cooperation sufficient to allow OCT testing and retinal photography
Who cannot join
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal 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.
- Participation in another ocular investigation or trial simultaneously.
- Systemic use of anti-VEGF within 3 months prior to day 0.
- Previous intravitreal ranibizumab within 3 months prior to day 0
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
- Any condition that, in the opinion of the investigator, would preclude participation in the study (e.g. chronic alcoholism, drug abuse).
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- Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
- An eye that, in the investigator's opinion, has no chance of improving in visual acuity following resolution of macular edema (e.g. presence of subretinal fibrosis, ischemic maculopathy or geographic atrophy).
- Presence of another ocular condition that may affect the visual acuity or macular edema during the course of the study (e.g. AMD, uveitis, Irvine-Gass).
- Evidence of active neovascularization of the iris or retina.
- Evidence of central atrophy or fibrosis in the study eye.
- Presence of substantial cataract, one that might decrease the vision by 3 or more lines of vision at sometime during the study.
- History of vitreous surgery in the study eye.
- History of cataract surgery within 6 months of enrollment.
- History of YAG capsulotomy within 2 months of enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreo-Retinal Associates, PC
Worcester, Massachusetts, 01605
About this study
This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).
Read the detailed description
Ranibizumab works by blocking Vascular Endothelial Growth Factor (VEGF), a substance which is found in eyes with diabetic eye disease and which causes leakage from blood vessels. Several studies have suggested that eyes with DME may have very high levels of VEGF; therefore, Ranibizumab may be helpful in blocking VEGF and decreasing DME.
Ranibizumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD) and Retinal Vein Occlusion at the dose amount of 0.5 mg. Ranibizumab has not been approved for use in subjects with DME.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Diabetic, Macular, Edema, Ranibizumab, anti-VEGF
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called lucentis
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
RanibizumabDrug
Also called lucentis
A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1:The PRN Group | Active comparator | You will receive 6 monthly intravitreal injections of 0.5% Ranibizumab administered about every 28 days. It is possible you may receive additional injections into the study eye for the next six months if certain criteria is met. Receives: Drug: Ranibizumab |
| arm 2:The Monthly Group: | Active comparator | You will receive 12 monthly intravitreal injections of 0.5% Ranibizumab administered every 28 days. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Acuity Scores at Month 12 Compared to Baseline
Measured: 12 months
Secondary outcomes (1)
Resolution of residual edema compared to baseline as determined by mean foveal thickness on Cirrus OCT 300 microns at Month 6 and Month 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Vitreo-Retinal Associates, PC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Frank J McCabe, M.D., Principal investigator, Vitreo-Retinal Associates, PCMarie V Lampson, Study director, Vitreo-Retinal Associates, PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472510
- Sponsor's protocol ID
- ML27906
- Status last verified
- Mar 2014
- First submitted
- 3 Nov 2011
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy
- ClinicalTrials.gov ID
- NCT01472510
- Acronym / sponsor ID
- ML27906
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic, Macular, Edema, Ranibizumab, anti-VEGF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vitreo-Retinal Associates, PCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Nov 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 is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).
Detailed description
Ranibizumab works by blocking Vascular Endothelial Growth Factor (VEGF), a substance which is found in eyes with diabetic eye disease and which causes leakage from blood vessels. Several studies have suggested that eyes with DME may have very high levels of VEGF; therefore, Ranibizumab may be helpful in blocking VEGF and decreasing DME.
Ranibizumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of wet age-related macular degeneration (AMD) and Retinal Vein Occlusion at the dose amount of 0.5 mg. Ranibizumab has not been approved for use in subjects with DME.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1:The PRN Group | Active comparator | Drug: RanibizumabYou will receive 6 monthly intravitreal injections of 0.5% Ranibizumab administered about every 28 days. It is possible you may receive additional injections into the study eye for the next six months if certain criteria is met. |
| arm 2:The Monthly Group: | Active comparator | Drug: RanibizumabYou will receive 12 monthly intravitreal injections of 0.5% Ranibizumab administered every 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects will be eligible if the following criteria are met:
Key exclusion criteria (15 listed)
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal 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.
- Participation in another ocular investigation or trial simultaneously.
- Systemic use of anti-VEGF within 3 months prior to day 0.
- Previous intravitreal ranibizumab within 3 months prior to day 0
- Blood pressure > 180/110 (systolic above 180 OR diastolic above 110)
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: lucentisA 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection | Drug | Arm 1:The PRN Group |
| RanibizumabAlso: lucentisA 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection | Drug | arm 2:The Monthly Group: |
Primary outcome
Change in Visual Acuity Scores at Month 12 Compared to Baseline
Time frame: 12 months
1 secondary outcome
Resolution of residual edema compared to baseline as determined by mean foveal thickness on Cirrus OCT 300 microns at Month 6 and Month 12.
Time frame: 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 14 Mar 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.
Frank J McCabe, M.D. principal investigator
Vitreo-Retinal Associates, PC
Marie V Lampson study director
Vitreo-Retinal Associates, PC
1 site 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 Macular Edema, run by Vitreo-Retinal Associates, PC 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 9 inclusion and 15 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 14 Mar 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 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?
Change in Visual Acuity Scores at Month 12 Compared to Baseline (time frame: 12 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 14 Mar 2014.