Persistent Diabetic Macular EdemaPhase 2NCT02127684
Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard antiVEGF Dosing
A Phase 2 study testing ranibizumab in people with Persistent Diabetic Macular Edema, run by Maturi, Raj K., M.D., P.C. at 1 site in United States.
Trial summary
The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2015
- 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:
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age >18 years
- Diagnosis of Type 1 or Type 2 diabetes
- BCVA score using the ETDRS method of >24 and <78 in the study eye at the screening visit
- 3 or more intravitreal injections of AntiVEGF over the 5 months prior to screening
- Presence of diabetic macular edema defined as SD-OCT CST >320 microns on spectral domain machine
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Anti-VEGF treatment in the study eye within 3 weeks prior to screening
- Intravitreal Ozurdex treatment in the study eye within 12 weeks prior to screening
- Intravitreal steroid treatment in the study eye within 8 weeks prior to screening
- PRP or focal laser in the study eye within 4 months prior to screening
- Active iris neovascularization in the study eye
Show all 13Show fewer
- Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result.
- History of cataract surgery in the study eye within 3 months prior to screening visit
- Uncontrolled systemic disease
- Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the screening visit
- Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception.
- Any condition or reason (including inability to read ETDRS chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study.
- Known allergy, hypersensitivity or contraindication to the study medications, its components, fluorescein or povidone iodine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing
The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.
Read the detailed description
This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.
- Conditions
- Persistent Diabetic Macular Edema
- Being tested
- ranibizumab
- Keywords
- diabetic macular edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
ranibizumab 0.3mg intravitreally monthly
ranibizumabDrug
Also called Lucentis
ranibizumab given every 2 weeks for 8 weeks then monthly as needed
| Study group | Role | What they receive |
|---|---|---|
| Standard Dosing Group | Active comparator | Standard Dosing Group will receive intravitreal injections of 0.3mg. ranibizumab at baseline, week 4 and 8 )sham injections at week 2 and 6). After week 8 retreatment will be given monthly if edema is greater than 290um or ETDRS visual acuity score <83 Receives: Drug: ranibizumab |
| Frequent dosing group | Experimental | Frequent dosing subjects will be evaluated and treated every two weeks through week 8 with intravitreal injection of 0.3mg ranibizumab. Subjects will then be evaluated monthly through week 24 and will receive treatment with ranibiumab based on residual edema and visual acuity Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Primary completionAug 2015 (estimated)
- Study completionNov 2015 (estimated)
Why it stopped: sponsor determined study design would not produce useful results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Responsible party
- Sponsor
- Investigators
- Raj K Maturi, MD, Principal investigator, Raj K. maturi MD PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127684
- Sponsor's protocol ID
- ML29381
- Status last verified
- Jul 2014
- First submitted
- 29 Apr 2014
- Last updated
- 30 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequent Dosing Regimen of Lucentis for Subjects With Persistent Diabetic Macular Edema Despite Standard AntiVEGF Dosing
- ClinicalTrials.gov ID
- NCT02127684
- Acronym / sponsor ID
- ML29381
- Conditions
- Persistent Diabetic Macular Edema
- Keywords
- diabetic macular edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: sponsor determined study design would not produce useful results
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maturi, Raj K., M.D., P.C.
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Nov 2015 (estimated)
- First posted
- 1 May 2014 (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.
The investigators would like to investigate the efficacy of more frequent treatment with Lucentis for subjects with persistent diabetic macular edema despite standard dosing regimen.
Detailed description
This is an open-label, subject masked, phase II study of intravitreally administered ranibizumab in subjects with persistent diabetic macular edema. Persistent diabetic macular edema is defined as subjects who still have central subfield thickness on SD-OCT of greater than 320 microns after having received at least 3 previous doses of AntiVEGF therapy in the past 5 months. Consented, enrolled subjects will be randomized into two subgroups: (1) standard dosing of monthly 0.3mg ranibizumab or (2) 0.3mg ranibizumab given 2 weeks apart for 5 doses followed by monthly dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dosing Group | Active comparator | Drug: ranibizumabStandard Dosing Group will receive intravitreal injections of 0.3mg. ranibizumab at baseline, week 4 and 8 )sham injections at week 2 and 6). After week 8 retreatment will be given monthly if edema is greater than 290um or ETDRS visual acuity score <83 |
| Frequent dosing group | Experimental | Drug: ranibizumabFrequent dosing subjects will be evaluated and treated every two weeks through week 8 with intravitreal injection of 0.3mg ranibizumab. Subjects will then be evaluated monthly through week 24 and will receive treatment with ranibiumab based on residual edema and visual acuity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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
- Diagnosis of Type 1 or Type 2 diabetes
- BCVA score using the ETDRS method of >24 and <78 in the study eye at the screening visit
- 3 or more intravitreal injections of AntiVEGF over the 5 months prior to screening
Key exclusion criteria (13 listed)
- Subjects who meet any of the following criteria will be excluded from this study:
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: Lucentisranibizumab 0.3mg intravitreally monthly | Drug | Standard Dosing Group |
| ranibizumabAlso: Lucentisranibizumab given every 2 weeks for 8 weeks then monthly as needed | Drug | Frequent dosing group |
Primary outcome
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
Time frame: 24 weeks
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization
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 30 Jul 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.
Raj K Maturi, MD principal investigator
Raj K. maturi MD 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 Persistent Diabetic Macular Edema, run by Maturi, Raj K., M.D., P.C. 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 7 inclusion and 13 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 30 Jul 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 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?
mean change in optical coherence topography central subfield thickness at 12 weeks and 24 weeks after randomization (time frame: 24 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 30 Jul 2014.