Diabetic Macular EdemaPhase 2READ 3NCT01077401
Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
A Phase 2 study testing Ranibizumab in people with Diabetic Macular Edema, run by Johns Hopkins University at 13 sites in United States.
Trial summary
The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients 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
- 152 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2010to Mar 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent and authorization of use and disclosure of protected health information
- Age ≥18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Serum HbA1c ≥ 5.5% within 12 months of randomization. Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea
- Diagnosis must be confirmed by fluorescein angiography and OCT images
- Foveal thickness of ≥ 250 μm,
- Best corrected visual acuity score in the study eye of 20/40 to 20/320 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). The non-study eye must be ≥ 20 letters (approximate Snellen equivalent 20/400).
- In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from DME and not from other obvious causes of decreased vision If a female of childbearing potential, a negative pregnancy test and commitment to the use of at least two forms of effective contraception (birth control) for the duration of the study are necessary.
Who cannot join
- Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
- Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
- Proliferative diabetic retinopathy in the study eye, with the exceptions of
- Inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal laser photocoagulation OR
- Tufts of neovascularization elsewhere (NVE) less than one disc area with no vitreous hemorrhage
Show all 26Show fewer
- Vitreomacular traction or epiretinal membrane in the study eye evident biomicroscopically or by optical coherence tomography (OCT)
- Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), macular ischemia, or organized hard exudate plaque
- Ocular disorders in the study eye that may confound interpretation of study results, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age related macular degeneration (AMD), ocular histoplasmosis, or pathologic myopia)
- Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the first 6-month study period
- Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum- Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
- History of vitreoretinal surgery in the study eye within 3 months of study entry
- Uncontrolled glaucoma (defined as intraocular pressure ≥30 mm Hg despite treatment with anti-glaucoma medications)
- Blood pressure exceeding 180/100 (sitting) during the screening period
- Uncontrolled diabetes mellitus, as evidenced by glycosylated hemoglobin (HbA1c) value >13%
- Renal failure requiring dialysis or renal transplant
- Premenopausal women unwilling to commit to adequate contraception
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug, might affect interpretation of the results of the study, or render the subject at high risk from treatment complications
- International normalized ratio (INR) ≥ 3.0 (e.g. due to current treatment with warfarin). The use of aspirin or other anticoagulants is not an exclusion
- History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
- Have a history of hypersensitivity to ranibizumab or any of its components
- Have the presence of active malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
- Other
- Inability to comply with study or follow-up procedures
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Texas Retina Associates
Arlington, Texas, 76012
Johns Hopkins University Wilmer Eye Institute
Baltimore, Maryland, 21287
Retina Vitreous Associates
Beverly Hills, California, 90211
Retina Group of Florida
Fort Lauderdale, Florida, 33334
Retina Institute of Hawaii
Honolulu, Hawaii, 96815
Illinois Retina Associates
Joliet, Illinois, 60435
Eye Care Specialists
Kingston, Pennsylvania, 18704
University of California San Diego
La Jolla, California, 92037
Doheny Eye Institute
Los Angeles, California, 90033
East Bay Retina Institute
Oakland, California, 94609
University of Kansas
Prairie Village, Kansas, 66208
Black Hills Eye Institute
Rapid City, South Dakota, 57701
Retina Macula Institute
Torrance, California, 90503
About this study
The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Diabetic, edema, DME
- 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
Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
ranibizumabDrug
Also called lucentis high-dose
Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5mg | Experimental | Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. Receives: Drug: Ranibizumab |
| Ranibizumab 2.0 mg | Experimental | Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deaths Due to Myocardial Infarction
Measured: 6 Months
Secondary outcomes (2)
Mean Change in Best Corrected Visual Acuity From Baseline to Month 6
Mean change in best corrected visual acuity (BCVA) (ETDRS) at 4 meters in the study eye over time through month 6.
Measured: baseline 6 Months
Mean Change in Retinal Thickness at Month 6
Measured: baseline to6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2012
- Study completionMar 2013
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 Macular EdemaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Diana V Do, MD, Principal investigator, Truhlsen Eye Institute, University of Nebraska Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077401
- Sponsor's protocol ID
- NA_00034586
- Acronym
- READ 3
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2010
- Last updated
- 28 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 With High Dose - the READ 3 Study
- ClinicalTrials.gov ID
- NCT01077401
- Acronym / sponsor ID
- READ 3 / NA_00034586
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic, edema, DME
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Feb 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Posted 28 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety, tolerability, bioactivity, and dose response of two different dosages (0.5 mg and 2.0 mg) of ranibizumab (RBZ) in patients with diabetic macular edema (DME).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5mg | Experimental | Drug: RanibizumabIntravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. |
| Ranibizumab 2.0 mg | Experimental | Drug: ranibizumabIntravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent and authorization of use and disclosure of protected health information
- Age ≥18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Serum HbA1c ≥ 5.5% within 12 months of randomization. Retinal thickening secondary to diabetes mellitus (diabetic macular edema) involving the center of the fovea
- Diagnosis must be confirmed by fluorescein angiography and OCT images
Key exclusion criteria (26 listed)
- Panretinal photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
- Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 3 months of study entry
- Previous participation in a study and receipt of anti-angiogenic drugs (pegaptanib sodium, ranibizumab, bevacizumab, anecortave acetate, protein kinase C inhibitor, etc.) within 2 months of study entry
- Proliferative diabetic retinopathy in the study eye, with the exceptions of
- Inactive, fibrotic proliferative diabetic retinopathy that has regressed following panretinal laser photocoagulation OR
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: lucentisIntravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria. | Drug | Ranibizumab 0.5mg |
| ranibizumabAlso: lucentis high-doseIntravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria. | Drug | Ranibizumab 2.0 mg |
Primary outcome
Deaths Due to Myocardial Infarction
Time frame: 6 Months
2 secondary outcomes
Mean Change in Best Corrected Visual Acuity From Baseline to Month 6
Time frame: baseline 6 Months
Mean Change in Retinal Thickness at Month 6
Time frame: baseline to6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- 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.
Diana V Do, MD principal investigator
Truhlsen Eye Institute, University of Nebraska Medical Center
13 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 Macular Edema, run by Johns Hopkins University at 13 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 8 inclusion and 26 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 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 28 Apr 2017). 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?
Deaths Due to Myocardial Infarction (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 28 Apr 2017.