Diabetic Macular EdemaPhase 1/2NCT02448446
The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Center Involved Edema and Lipid Exudates
A Phase 1/2 study testing ranibizumab 0.3mg in people with Diabetic Macular Edema and Hard Lipid Exudates, run by South Coast Retina Center; Carson, McBeath, Boswell, Inc. at 4 sites in United States.
Trial summary
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema, Hard Lipid Exudates
- What is being tested?
- ranibizumab 0.3mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2015to May 2018
- Phase
- Phase 1/2
- 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
- Type 1 or Type 2 Diabetes mellitus
- Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24
- Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss
- Retinal thickness measured on spectral domain optical coherence tomography (OCT). Zeiss Cirrus: ≥290μm in women and ≥305 μm in men in the central subfield. Heidelberg Spectralis: ≥305μm in women and ≥320 μm in men in the central subfield
- Lipid exudates involving the central subfield on spectral domain OCT.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Treatment for diabetic macular edema within the prior 4 months.
- Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months
- major ocular surgery within the prior 4 months
- myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization
- Pregnancy (positive pregnancy test) or lactation
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- 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 intrauterine device (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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
South Coast Retina Center; Carson, McBeath, Boswell, Inc
Huntington Beach, California, 92647
South Coast Retina Center; Carson, McBeath, and Boswell, Inc
Long Beach, California, 90505
Retina Partners
Santa Monica, California, 90404
South Coast Retina Center; Carson, McBeath, Boswell, Inc
Torrance, California, 90505
About this study
Official title: The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Read the detailed description
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
- Conditions
- Diabetic Macular Edema, Hard Lipid Exudates
- Being tested
- ranibizumab 0.3mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab 0.3mgDrug
Also called Lucentis
intravitreally administered
| Study group | Role | What they receive |
|---|---|---|
| Diabetic macular edema treatment group (Group 1) | Active comparator | Treatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. Receives: Drug: ranibizumab 0.3mg |
| Diabetic macular edema and lipid treatment group (Group 2) | Active comparator | Continued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. Receives: Drug: ranibizumab 0.3mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
Measured: 6-12 months
Secondary outcomes (8)
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Measured: 12 months
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Measured: 12 months
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
Measured: 12 months
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Measured: 12 months
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
Measured: 12 months
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Measured: 12 months
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
Measured: 12 months
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
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 posted19 May 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2018
- Study completionMay 2018
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Coast Retina Center; Carson, McBeath, Boswell, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Doheny Image Reading Center, The Retina Partners
- Responsible party
- Principal investigator, Julie Gasperini, M.D., South Coast Retina Center; Carson, McBeath, Boswell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448446
- Sponsor's protocol ID
- ML259577
- Status last verified
- Jul 2021
- First submitted
- 5 Mar 2015
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitreal Ranibizumab on Visual Acuity and Hard Exudate Resolution in the Treatment of Diabetic Macular Edema With Foveal Involving Edema and Lipid Exudates
- ClinicalTrials.gov ID
- NCT02448446
- Acronym / sponsor ID
- ML259577
- Conditions
- Diabetic Macular Edema, Hard Lipid Exudates
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- South Coast Retina Center; Carson, McBeath, Boswell, Inc.University, hospital or other
- Collaborators
- Genentech, Inc., Doheny Image Reading Center, The Retina Partners
- Study start
- Aug 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 19 May 2015 (estimated)
- Results
- Posted 8 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Detailed description
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab in subjects with diabetic macular edema and lipid exudates in the central subfield.
Consented, enrolled subjects will receive multiple open-label intravitreal injections on 0.3mg ranibizumab administered every 30 days for 12 months per the treatment algorithm.
The patients will be randomized to 1 of 2 treatment groups. Group 1: Treatment algorithm based on the Diabetic Retinopathy Clinical Research (DRCR) protocol I 4:2:7 strategy based on the presence of macular edema.
Group 2: Continue treatment until not only the macular edema is resolved but also until the lipid exudate is resolved.
Sample size: 30 eyes Follow-up Schedule: Every 4 weeks throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic macular edema treatment group (Group 1) | Active comparator | Drug: ranibizumab 0.3mgTreatment using intravitreal ranibizumab 0.3mg based on the DRCR protocol I 4:2:7 strategy based on the presence of macular edema. |
| Diabetic macular edema and lipid treatment group (Group 2) | Active comparator | Drug: ranibizumab 0.3mgContinued treatment with intravitreal ranibizumab 0.3mg until, not only the macular edema is resolved, but also until the lipid exudate is resolved. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age ≥ 18 years
- Type 1 or Type 2 Diabetes mellitus
- Best corrected ETDRS visual acuity (20/32-20/320) or letter score 78 to 24
- Diabetic macular edema on clinical examination involving the center of the macula assessed to be the main cause of visual loss
Key exclusion criteria (9 listed)
- Treatment for diabetic macular edema within the prior 4 months.
- Panretinal photocoagulation within the prior 4 months or anticipated need for panretinal photocoagulation within the next 6 months
- major ocular surgery within the prior 4 months
- myocardial infarction, other cardiac event requiring hospitalization, cerebrovascular accident, transient ischemic attack, or treatment for acute congestive heart failure occurred within 4 months before randomization
- Pregnancy (positive pregnancy test) or lactation
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 0.3mgAlso: Lucentisintravitreally administered | Drug | Diabetic macular edema and lipid treatment group (Group 2), Diabetic macular edema treatment group (Group 1) |
Primary outcome
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months
Time frame: 6-12 months
Compare Group 1 and Group 2 for best correct visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 4 meters.
8 secondary outcomes
Percentage of Eyes With Improvement of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Percentage of Eyes With Complete Resolution of Lipid Deposits in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Number of Eyes With Complete Resolution in the Central Subfield as Measured on OCT and Fundus Photography
Time frame: 12 months
Percentage of Eyes With Improvement in Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame: 12 months
Percentage of Patients With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured on OCT and Fundus Photography
Time frame: 12 months
Number of Eyes With Complete Resolution of Lipid Deposits Throughout the Macular Grid as Measured by OCT and Fundus Photography
Time frame: 12 months
Incidence and Severity of Ocular Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Incidence and Severity of Other Adverse Events as a Measure of Safety and Tolerability
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab 0.3mg in people with Diabetic Macular Edema and Hard Lipid Exudates, run by South Coast Retina Center; Carson, McBeath, Boswell, Inc. at 4 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 7 inclusion and 9 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 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 combined 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.
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 8 Jul 2021). 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?
Best Corrected Visual Acuity as Measured by ETDRS at 6 and 12 Months (time frame: 6-12 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 8 Jul 2021.