Diabetic Macular EdemaPhase 1/2ROTATENCT01845844
Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab
A Phase 1/2 study testing Ranibizumab 0.3mg/0.05cc in people with Diabetic Macular Edema, run by Southeast Retina Center, Georgia at 1 site in United States.
Trial summary
This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9… 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
- What is being tested?
- Ranibizumab 0.3mg/0.05cc
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jan 2015
- Phase
- Phase 1/2
- 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
- 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.
- >=18 years
- Type I/II diabetes mellitus
- Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)
- Definite retinal thickening due to diabetic macular edema involving the center of the macula.
- Media clarity, pupillary dilation and individual cooperation for adequate fungus photography and fluorescein angiography.
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- Visual Acuity score in study eye <=80 and >=20 (approximate Snellen equivalent 20/25 to 20/400).
- History of at least 6 intravitreal bevacizumab injections within the past 9 months and 2 intravitreal bevacizumab injections within the past 2 months.
- No history of an anti-VEGF treatment for DME in the past 3 weeks.
- No other DME treatment for DME, other than bevacizumab, in the study eye at any time in the past 3 months.
- No history of major ocular surgery in the study eye within prior 3 months or anticipated within the next six months following randomization.
Who cannot join
- Pregnancy or lactation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another medical investigation or trial within 30 days of randomization
- Known allergy to ranibizumab
- Acute cardiovascular event requiring hospitalization within the past 3 months
- Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization or anticipated use during the study
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- Macular edema is considered to be due to a cause other than DME
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from the resolution of macular edema
- History of intravitreal anti-vascular endothelial growth factor (anti-VEGF) agent other than bevacizumab within 9 months prior to randomization
- History of panretinal photocoagulation within 3 months prior to randomization or anticipated need for panretinal photocoagulation in the 6 months following randomization
- Yag capsulotomy performed within 1 month prior to randomization
- External ocular infection including conjunctivitis, significant blepharitis, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Southeast Retina Center, PC
Augusta, Georgia, 30909
Dennis M Marcus, MD, 706-650-0061, dmarcus@southeastretina.com
Jared Gardner, BS, 706-650-0061, jgardner@southeastretina.com
About this study
Official title: Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab (ROTATE Trial)
This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).
Read the detailed description
30 eyes will be randomized in a 1:2 ratio (Group A= 10 patients; Group B= 20 patients) Group A: ("monthly group")- Consented patient with enrolled eye will receive 12 monthly required injections of 0.3mg ranibizumab over 1 year OR Group B: ("As needed (PRN) Group")- Consented patient with enrolled eye will receive 6 monthly required injections of 0.3mg ranibizumab for 6 months, followed by as needed (PRN) dosing (required ranibizumab if DME persistent on Optical Coherence Tomography (OCT) and Early Treatment Diabetic Retina Study (ETDRS) Best Corrected Visual Acuity (BCVA) <20/20) for 6 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab 0.3mg/0.05cc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.3mg/0.05ccDrug
Also called Lucentis
Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months.
Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.3mg (12 months) | Experimental | Intravitreal injection of ranibizumab 0.3mg/0.05cc Receives: Drug: Ranibizumab 0.3mg/0.05cc |
| Ranibizumab 0.3mg (6 months) | Active comparator | Intravitreal injection of ranibizumab 0.3mg/0.05cc Receives: Drug: Ranibizumab 0.3mg/0.05cc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
Measured: 1 year
Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
Measured: 1 year
Secondary outcomes (1)
Efficacy of monthly and monthly followed by PRN dosing of 0.3 mg ranibizumab after persistent DME despite previous bevacizumab therapy
Examples include proportion of eyes with absence of fluorescein angiographic macular leakage at 12 months; proportion of eyes with unchanged, worsened, or improved fluorescein angiographic macular leakage from baseline at 1, 6 and 12 months; proportion of eyes with unchanged, worsened, or improved fundus photographic DME appearance from baseline at 1, 6 and 12 months; proportion of eyes with new vitreous hemorrhage or traction retinal detachment secondary to Proliferative Diabetic Retinopathy (PDR); proportion of eyes with progression from baseline Non-proliferative Diabetic Retinopathy (NPDR) to PDR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast Retina Center, Georgia
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Dennis M. Marcus, M.D., Southeast Retina Center, Georgia
- Investigators
- Dennis M Marcus, M.D., Study director, Southeast Retina Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845844
- Sponsor's protocol ID
- ML28713
- Acronym
- ROTATE
- Status last verified
- Sep 2014
- First submitted
- 2 Apr 2013
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranibizumab For Persistent Diabetic Macular Edema After Bevacizumab (ROTATE Trial)
- ClinicalTrials.gov ID
- NCT01845844
- Acronym / sponsor ID
- ROTATE / ML28713
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Southeast Retina Center, GeorgiaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 3 May 2013 (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.
This is an open-label, Phase I/II study of Intravitreally administered 0.3mg ranibizumab in subjects with persistent Diabetic Macular Edema (DME) after recent and frequent bevacizumab (at least 2 bevacizumab intravitreal injections within 2 months prior to enrollment and at least 6 bevacizumab injections within 9 months of enrollment).
Detailed description
30 eyes will be randomized in a 1:2 ratio (Group A= 10 patients; Group B= 20 patients) Group A: ("monthly group")- Consented patient with enrolled eye will receive 12 monthly required injections of 0.3mg ranibizumab over 1 year OR Group B: ("As needed (PRN) Group")- Consented patient with enrolled eye will receive 6 monthly required injections of 0.3mg ranibizumab for 6 months, followed by as needed (PRN) dosing (required ranibizumab if DME persistent on Optical Coherence Tomography (OCT) and Early Treatment Diabetic Retina Study (ETDRS) Best Corrected Visual Acuity (BCVA) <20/20) for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.3mg (12 months) | Experimental | Drug: Ranibizumab 0.3mg/0.05ccIntravitreal injection of ranibizumab 0.3mg/0.05cc |
| Ranibizumab 0.3mg (6 months) | Active comparator | Drug: Ranibizumab 0.3mg/0.05ccIntravitreal injection of ranibizumab 0.3mg/0.05cc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study.
- >=18 years
- Type I/II diabetes mellitus
- Central-involved DME in study eye (OCT CSF >=275um on Heidelberg Spectralis spectral domain OCT with evidence of intraretinal or subretinal fluid or cysts)
- Definite retinal thickening due to diabetic macular edema involving the center of the macula.
Key exclusion criteria (12 listed)
- Pregnancy or lactation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another medical investigation or trial within 30 days of randomization
- Known allergy to ranibizumab
- Acute cardiovascular event requiring hospitalization within the past 3 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 |
|---|---|---|
| Ranibizumab 0.3mg/0.05ccAlso: LucentisGroup A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months. Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria. | Drug | Ranibizumab 0.3mg (12 months), Ranibizumab 0.3mg (6 months) |
Primary outcome
Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups
Time frame: 1 year
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
Severity of ocular and systemic adverse events will be compared between experimental and active comparator groups
Time frame: 1 year
Examples include worsened acuity of greater than 30 letters, retinal detachment, endophthalmitis, cataract progression, vitreous hemorrhage, new PDR or neovascularization of the iris or angle, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs and will include thromboembolic events, deaths and systemic serious adverse events
1 secondary outcome
Efficacy of monthly and monthly followed by PRN dosing of 0.3 mg ranibizumab after persistent DME despite previous bevacizumab therapy
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 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.
Dennis M Marcus, M.D. study director
Southeast Retina Center
1 site 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/0.05cc in people with Diabetic Macular Edema, run by Southeast Retina Center, Georgia 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 11 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dennis M Marcus, M.D. (706-650-0061, dmarcus@southeastretina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ocular and systemic adverse events will be compared between experimental and active comparator groups (time frame: 1 year). The study lists 2 primary outcomes in all. 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 17 Sep 2014.