Diabetic Macular EdemaPhase 1/2REACTNCT01982435
Safety and Efficacy of Ranibizumab for Diabetic Macular Edema
A Phase 1/2 study testing Ranibizumab in people with Diabetic Macular Edema, run by Justis Ehlers at 2 sites in United States.
Trial summary
The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin). 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
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2014to 26 May 2016
- 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
- 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
- ETDRS best-corrected visual acuity of 20/25 to 20/320 in the study eye
- Willing, committed, and able to return for ALL clinic visits and complete all study related procedures
- At least 6 previous bevacizumab injections for diabetic macular edema in the last 12 months in the study eye.
- At least 2 bevacizumab injections within 10 weeks and the most recent bevacizumab injection within 6 weeks of baseline study visits in the study eye.
- Persistent foveal-involving diabetic macular edema based on presence of intraretinal and/or subretinal fluid by SDOCT in the foveal center at study entry in the study eye.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study:
- Pregnancy (positive pregnancy test) or lactation
- 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 IUD (intrauterine device), or contraceptive hormone implant or patch.
- Intravitreal steroid or periocular steroid treatment within 3 months of study entry in the study eye.
- Focal/grid laser photocoagulation treatment within 3 months of study entry in the study eye.
- Panretinal photocoagulation treatment within 3 months of study entry in the study eye.
Show all 21Show fewer
- Prior vitrectomy in the study eye
- History of retinal detachment in the study eye
- Prior trabeculectomy or other filtration surgery in the study eye
- Active intraocular inflammation in either eye
- Active ocular or periocular infection in either eye
- Active scleritis or episcleritis in either eye
- History of any other retinal vascular disease (e.g., retinal vein occlusion, retinal artery occlusion) in the study eye.
- Coexistent retinal disease other than diabetic retinopathy (e.g., AMD (age related macular degeneration), inherited retinal disease) in the study eye.
- Intraocular surgery within 3 months of study entry in the study eye.
- History of corneal transplant or corneal dystrophy in the study eye.
- Significant media opacities in study eye which may interfere with visual acuity in the study eye.
- Participation as a subject in any clinical study within 3 months of study entry.
- History of allergy to topical iodine
- 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
2 sites in 1 country.
United States2 sites
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
Cole Eye Institute at Hillcrest Hospital
Mayfield Heights, Ohio, 44124
About this study
Official title: Safety and Efficacy of Intravitreal Ranibizumab for Diabetic Macular Edema Previously Treated With Intravitreal Bevacizumab: A Randomized Dual Arm Comparative Dosing Trial
The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).
Read the detailed description
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab (Lucentis) in subjects with DME (diabetic macular edema) previously treated with intravitreal bevacizumab (Avastin) with a randomized comparative dosing strategy, monthly vs "treat-and-extend." Thirty patients total will be enrolled in the study, 15 in each group. This study will have a 1-year treatment period. The recruitment period will occur over 1 year with total potential study duration of 2 years.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Diabetes, Macular Edema
- Medical subject headings
- Diabetes Mellitus, 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
Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
RanibizumabDrug
Also called Lucentis
Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Group I - Monthly | Other | Enrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. Receives: Drug: Ranibizumab |
| Group II - Treat-and-Extend | Other | Enrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Non-severe Ocular Adverse Events
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Measured: 12 months
Number of Participants With Severe Ocular Adverse Events
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.
Measured: 12 months
Number of Participants With Non-severe Non-ocular Adverse Event
As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Measured: 12 months
Number of Participants With Severe Non-ocular Adverse Event
As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Measured: 12 months
Secondary outcomes (8)
Mean Change in BCVA
Mean change in best-corrected visual acuity as assessed by the number of letters read correctly on the electronic ETDRS eye chart from baseline to months 6 and 12.
Measured: Months 6 and 12
Mean Change in Central Foveal Thickness
Mean absolute change from baseline central foveal thickness at months 6 and 12 as measured by SDOCT (defined as the average thickness within the central 1 mm subfield)
Measured: Months 6 and 12
Anatomically Dry Eyes by SDOCT
Number of participants with an anatomically "dry" study eye by SDOCT at months 6 and 12
Measured: Months 6 and 12
Gain in Vision Greater Than or Equal to 15 Letters
Number of participants that gained greater than or equal to 15 letters of vision in their study eye at months 6 and 12.
Measured: Months 6 and 12
Loss in Vision Greater Than or Equal to 15 Letters
Number of participants that lost greater than or equal to 15 letters of vision in their study eye at months 6 and 12.
Measured: Months 6 and 12
Participants With BCVA at 20/40 or Better
Number of participants with 20/40 or better best-corrected visual acuity in their study eye at months 6 and 12.
Measured: Months 6 and 12
Number of Participants With Angiographic Leakage
Number of participants with angiographic leakage in their study eye measured from baseline to months 3, 6 and 12 (i.e. presence of leakage).
Measured: 3, 6 and 12 months
Number of Participants With Nonperfusion
Number of participants with peripheral nonperfusion in their study eye from baseline to months 3, 6, and 12 (i.e. presence of ischemia).
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start24 Jun 2014
- Primary completion26 May 2016
- Study completion26 May 2016
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justis Ehlers
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Justis Ehlers, The Cleveland Clinic
- Investigators
- Justis Ehlers, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982435
- Sponsor's protocol ID
- REACT Study
- Acronym
- REACT
- Status last verified
- Oct 2020
- First submitted
- 29 Oct 2013
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Intravitreal Ranibizumab for Diabetic Macular Edema Previously Treated With Intravitreal Bevacizumab: A Randomized Dual Arm Comparative Dosing Trial
- ClinicalTrials.gov ID
- NCT01982435
- Acronym / sponsor ID
- REACT / REACT Study
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetes, Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Justis EhlersUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 24 Jun 2014 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 26 May 2016 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 1 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to assess the ocular and systemic adverse events of ranibizumab (Lucentis)for DME (diabetic macular edema) following previous treatment with intravitreal bevacizumab (Avastin).
Detailed description
This is an open-label, Phase I/II study of intravitreally administered 0.3mg ranibizumab (Lucentis) in subjects with DME (diabetic macular edema) previously treated with intravitreal bevacizumab (Avastin) with a randomized comparative dosing strategy, monthly vs "treat-and-extend." Thirty patients total will be enrolled in the study, 15 in each group. This study will have a 1-year treatment period. The recruitment period will occur over 1 year with total potential study duration of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I - Monthly | Other | Drug: RanibizumabEnrolled subjects will receive multiple open-label intravitreal injections of 0.3 mg ranibizumab administered every 28 days (+/- 7 days from the last treatment) for 12 months in the monthly group. |
| Group II - Treat-and-Extend | Other | Drug: RanibizumabEnrolled subjects will initially receive 3 loading doses of open-label Ranibizumab 0.3 mg given via intravitreal injection every 28 days (+/- 7 days from the last treatment). After the third loading dose, the follow-up interval is determined by the Principal Investigator based on OCT results as stated in the protocol. The follow-up interval is increased by 2 weeks (+/- 7 days) at each visit up to a maximum interval of 12 weeks (+/- 7 days). There is criteria built into the protocol in case a reduction in the follow-up intervals becomes necessary based upon worsening OCT results. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be eligible if the following criteria are met:
Key exclusion criteria (21 listed)
- Pregnancy (positive pregnancy test) or lactation
- 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 IUD (intrauterine device), or contraceptive hormone implant or patch.
- Intravitreal steroid or periocular steroid treatment within 3 months of study entry in the study eye.
- Focal/grid laser photocoagulation treatment within 3 months of study entry in the study eye.
- Panretinal photocoagulation treatment within 3 months of study entry in the study eye.
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: LucentisMonthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema. | Drug | Group I - Monthly |
| RanibizumabAlso: LucentisThree Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months. | Drug | Group II - Treat-and-Extend |
Primary outcome
Number of Participants With Non-severe Ocular Adverse Events
Time frame: 12 months
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Number of Participants With Severe Ocular Adverse Events
Time frame: 12 months
As identified by eye examination (including visual acuity testing), identified by physical examination, subject reporting, and changes in vital signs.
Number of Participants With Non-severe Non-ocular Adverse Event
Time frame: 12 months
As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
Number of Participants With Severe Non-ocular Adverse Event
Time frame: 12 months
As identified by physical examination, subject reporting, and changes in vital signs. These outcome measures are also included in more detail in the adverse event section of the results.
8 secondary outcomes
Mean Change in BCVA
Time frame: Months 6 and 12
Mean Change in Central Foveal Thickness
Time frame: Months 6 and 12
Anatomically Dry Eyes by SDOCT
Time frame: Months 6 and 12
Gain in Vision Greater Than or Equal to 15 Letters
Time frame: Months 6 and 12
Loss in Vision Greater Than or Equal to 15 Letters
Time frame: Months 6 and 12
Participants With BCVA at 20/40 or Better
Time frame: Months 6 and 12
Number of Participants With Angiographic Leakage
Time frame: 3, 6 and 12 months
Number of Participants With Nonperfusion
Time frame: 3, 6 and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- 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.
Justis Ehlers, M.D. principal investigator
The Cleveland Clinic
2 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 in people with Diabetic Macular Edema, run by Justis Ehlers at 2 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 21 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 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 1 Aug 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?
Number of Participants With Non-severe Ocular Adverse Events (time frame: 12 months). The study lists 4 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 3 Nov 2020.