Diabetic Macular EdemaPhase 2NCT01253694
Ranibizumab as a Rescue Therapy for Diabetic Macular Edema
A Phase 2 study testing injection of 0.5 mg of Intravitreal Ranibizumab in people with Diabetic Macular Edema, run by New England Retina Associates at 1 site in United States.
Trial summary
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- injection of 0.5 mg of Intravitreal Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2012
- 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 to 90 years
- 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 Spectralis OCT (optical coherence tomography) > 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 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).
- BCVA of 20/32-20/400 using Early Treatment Diabetic Retinopathy Study (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.
- Participation in another ocular investigation or trial simultaneously.
- Systemic use of anti-VEGF 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).
- Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be contributing to the macular edema.
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- 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. Age-related Macular Degeneration, 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
New England Retina Associates
Norwich, Connecticut, 06360
About this study
Official title: Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
- Conditions
- Diabetic Macular Edema
- Being tested
- injection of 0.5 mg of Intravitreal Ranibizumab
- Keywords
- Diabetes, edema, ranibizumab, bevacizumab, refractory
- Medical subject headings
- Diabetes Mellitus, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of 0.5 mg of Intravitreal RanibizumabDrug
Also called Lucentis
Following the sterile technique, intravitreal injection of anti-VEGF is applied
| Study group | Role | What they receive |
|---|---|---|
| Patients with 3-5 consecutive Avastin injections | Experimental | These patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months. Receives: Drug: injection of 0.5 mg of Intravitreal Ranibizumab |
| Patients with 6 or more consecutive injections of Bevacizumab | Experimental | Patients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months. Receives: Drug: injection of 0.5 mg of Intravitreal Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.
Measured: 6 months
Secondary outcomes (1)
Evaluate the main change in BCVA (best corrected visual acuity) score over time
They will evaluate the amount of patients gaining 3 or more letters and the amount of patients losing 3 or more letters.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionJun 2012 (estimated)
- Study completionJul 2012 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New England Retina Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nauman Chaudhry, MD, Principal investigator, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253694
- Sponsor's protocol ID
- DME-NERA
- Status last verified
- May 2013
- First submitted
- 30 Nov 2010
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab in Residual Diabetic Macular Edema Following Previous Intravitreal Bevacizumab Therapy
- ClinicalTrials.gov ID
- NCT01253694
- Acronym / sponsor ID
- DME-NERA
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes, edema, ranibizumab, bevacizumab, refractory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New England Retina AssociatesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 3 Dec 2010 (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.
Treatment with Ranibizumab of the residual diabetic edema in patients with failed response to Bevacizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with 3-5 consecutive Avastin injections | Experimental | Drug: injection of 0.5 mg of Intravitreal RanibizumabThese patients will receive 0.5 mg of intravitreal Ranibizumab monthly for 6 months. |
| Patients with 6 or more consecutive injections of Bevacizumab | Experimental | Drug: injection of 0.5 mg of Intravitreal RanibizumabPatients will receive 0.5 mg of intravitreal Ranibizumab during the first 6 months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Diagnosis of diabetes mellitus (type 1 or 2)
- Residual edema as determined by mean foveal thickness on Spectralis OCT (optical coherence tomography) > 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 3-5 or more consecutive 1.25 mg of intravitreal bevacizumab injections for the treatment of diabetic macular edema (consecutive injections administered no more than 6 weeks apart).
Key exclusion criteria (14 listed)
- Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women not using adequate contraception.
- Participation in another ocular investigation or trial simultaneously.
- Systemic use of anti-VEGF 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).
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 |
|---|---|---|
| injection of 0.5 mg of Intravitreal RanibizumabAlso: LucentisFollowing the sterile technique, intravitreal injection of anti-VEGF is applied | Drug | Patients with 3-5 consecutive Avastin injections, Patients with 6 or more consecutive injections of Bevacizumab |
Primary outcome
Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns.
Time frame: 6 months
1 secondary outcome
Evaluate the main change in BCVA (best corrected visual acuity) score over time
Time frame: 6-12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
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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.
Nauman Chaudhry, MD principal investigator
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 2 study testing injection of 0.5 mg of Intravitreal Ranibizumab in people with Diabetic Macular Edema, run by 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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 3 May 2013. 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 was withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects with resolution of diabetic macular edema compared to baseline as determined by mean foveal thickness on Spectralis < 300 microns. (time frame: 6 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 3 May 2013.