Diabetic Macular EdemaPhase 4NCT03097068
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
A Phase 4 study testing Lucentis in people with Diabetic Macular Edema, run by Vitreo-Retinal Associates, Michigan at 1 site in United States.
Trial summary
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis. 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?
- Lucentis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2017to 2 Feb 2018
- Phase
- Phase 4
- 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
- Diagnosis of diabetes mellitus
- Best corrected visual acuity 20/32 - 20/320
- Diabetic macular edema involving the center of the macula
- Optical coherence tomography central subfield thickness of at least 250 microns
Who cannot join
- History of anti-vascular endothelial growth factor treatment in the past 12 months
- Any diabetic macular edema treatment in the past 4 months
- Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49546
About this study
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.
Read the detailed description
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LucentisDrug
Also called Aqueous Tap
0.3mg Lucentis
| Study group | Role | What they receive |
|---|---|---|
| 0.3 mg Lucentis | Experimental | Aqueous Humor sample post injection of 0.3 mg Lucentis Receives: Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular Endothelial Growth Factor Levels
An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start19 Apr 2017
- Primary completion6 Dec 2017
- Study completion2 Feb 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 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitreo-Retinal Associates, Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Michigan State University
- Responsible party
- Principal investigator, Louis C Glazer, MD, Vitreo-Retinal Associates, Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097068
- Sponsor's protocol ID
- ML39638
- Status last verified
- Oct 2022
- First submitted
- 21 Mar 2017
- Last updated
- 24 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
- ClinicalTrials.gov ID
- NCT03097068
- Acronym / sponsor ID
- ML39638
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vitreo-Retinal Associates, MichiganUniversity, hospital or other
- Collaborators
- Genentech, Inc., Michigan State University
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 24 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.
Detailed description
Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.3 mg Lucentis | Experimental | Drug: LucentisAqueous Humor sample post injection of 0.3 mg Lucentis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of diabetes mellitus
- Best corrected visual acuity 20/32 - 20/320
- Diabetic macular edema involving the center of the macula
- Optical coherence tomography central subfield thickness of at least 250 microns
Key exclusion criteria (3 listed)
- History of anti-vascular endothelial growth factor treatment in the past 12 months
- Any diabetic macular edema treatment in the past 4 months
- Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months
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 |
|---|---|---|
| LucentisAlso: Aqueous Tap0.3mg Lucentis | Drug | 0.3 mg Lucentis |
Primary outcome
Vascular Endothelial Growth Factor Levels
Time frame: 12 weeks
An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lucentis in people with Diabetic Macular Edema, run by Vitreo-Retinal Associates, Michigan 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 4 inclusion and 3 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 24 Oct 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 24 Oct 2022). 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?
Vascular Endothelial Growth Factor Levels (time frame: 12 weeks). 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 24 Oct 2022.