Diabetic Macular EdemaPhase 2NCT02363621
Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs Aflibercept in Patients With DME
A Phase 2 study testing Ranibizumab 0.3 mg and Aflibercept 2.0 mg in people with Diabetic Macular Edema, run by Arshad Khanani at 1 site in United States.
Trial summary
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME. The investigators will be evaluating patients (1-7 days) post injections for: 1. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ranibizumab 0.3 mg and Aflibercept 2.0 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Oct 2017
- Phase
- Phase 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 21 years and older
- All sexes
- Healthy volunteers accepted
- 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 > 21 years
- Exam and OCT confirming Diabetic Macular Edema
- Visual Acuity of 20/400 or better
- No history of post injection pain or inflammation in the past
Who cannot join
- Subjects who meet any of the following criteria will be excluded from this study
- History of Endophthalmitis in either eye
- Current inflammation in either eye
- Uncontrolled or symptomatic Dry Eye Syndrome
- Intravitreal injection less than 3 months ago
- History of Anterior or Posterior Uveitis
Show all 10Show fewer
- History of post injection pain with prior treatments
- Recent thromboembolic event (<3 months)
- Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.
The investigators will be evaluating patients (1-7 days) post injections for:
- Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).
Read the detailed description
This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating Scale.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab 0.3 mg, Aflibercept 2.0 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.3 mgDrug
Also called Lucentis
Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg
Aflibercept 2.0 mgDrug
Also called Eylea
Patient will receive intravitreal injection of Aflibercept 2.0 mg
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.3 Intravitreal injection | Active comparator | Intravitreal injection of Ranibizumab 0.3 mg once Receives: Drug: Ranibizumab 0.3 mg |
| Aflibercept 2.0 mg intravitreal injection | Active comparator | Intravitreal Aflibercept 2.0 mg once Receives: Drug: Aflibercept 2.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Intraocular Inflammation
Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.
Measured: 24 to 48 hours (visit #1)
Number of Participants With Intraocular Inflammation
Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam
Measured: 5 to 7 days (visit #2)
Secondary outcomes (1)
Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.
Pain score rated on a 11 point numerical rating from 0-10 administered to each patient verbally at visit #1 and visit #2.
0 = no pain 10 = severe pain
Measured: 24 to 48 hours visit #1 and 5 to 7 days visit #2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionOct 2017
- Study completionOct 2017
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arshad Khanani
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Arshad Khanani, Sierra Eye Associates
- Investigators
- Arshad Khanani, MD, Principal investigator, Sierra Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363621
- Sponsor's protocol ID
- ML29634
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2015
- Last updated
- 26 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inflammation and Pain Post Injection of Ranibizumab vs. Aflibercept in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02363621
- Acronym / sponsor ID
- ML29634
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Arshad KhananiUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Posted 26 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of ranibizumab 0.3mg and aflibercept 2.0mg in patients with DME.
The investigators will be evaluating patients (1-7 days) post injections for:
- Intraocular inflammation (defined as anterior chamber and/or vitreous cells 2. Pain (as measured on a standardized pain scale).
Detailed description
This is an open-label, Phase II study of post injection pain and inflammation after intravitreally administered ranibizumab and aflibercept in 100 subjects with Diabetic Macular Edema. Treatment naïve and experienced patients will be enrolled. Treatment experienced patients with history of anti-vegf injections will be eligible as long as they have not received any intravitreal injection in the 3 months prior to the study visit. Patients will be randomized to receive either Lucentis 0.3 mg or Eylea 2.0 mg, and followed for a week. A non-injecting masked physician who is blinded to the treatment drug will evaluate the patient at baseline before the injection and then within 1-2 days and 5-7 days after the injection for anterior chamber and vitreous cells using slit lamp examination and indirect ophthalmoscopy. Pain will also be recorded at these visits using a standardized pain scale.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.3 mg ranibizumab or 2.0 mg aflibercept. A standard intravitreal injection protocol will be followed. Patients will be revaluated at baseline, 1-2 days and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber and vitreous inflammation; this physician will be blinded about the specific treatment. Anterior chamber inflammation is described as any cell or flare in the anterior chamber. These will be evaluated using Standardization of Uveitis Nomenculature (SUN) working group classifications. Pain score will be evaluated using a Numerical Rating Scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.3 Intravitreal injection | Active comparator | Drug: Ranibizumab 0.3 mgIntravitreal injection of Ranibizumab 0.3 mg once |
| Aflibercept 2.0 mg intravitreal injection | Active comparator | Drug: Aflibercept 2.0 mgIntravitreal Aflibercept 2.0 mg once |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 > 21 years
- Exam and OCT confirming Diabetic Macular Edema
- Visual Acuity of 20/400 or better
Key exclusion criteria (10 listed)
- Subjects who meet any of the following criteria will be excluded from this study
- History of Endophthalmitis in either eye
- Current inflammation in either eye
- Uncontrolled or symptomatic Dry Eye Syndrome
- Intravitreal injection less than 3 months ago
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 0.3 mgAlso: LucentisRanibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg | Drug | Ranibizumab 0.3 Intravitreal injection |
| Aflibercept 2.0 mgAlso: EyleaPatient will receive intravitreal injection of Aflibercept 2.0 mg | Drug | Aflibercept 2.0 mg intravitreal injection |
Primary outcome
Number of Participants With Intraocular Inflammation
Time frame: 24 to 48 hours (visit #1)
Number of participants with intraocular inflammation as seen on slide lamp and dilated fundus exam.
Number of Participants With Intraocular Inflammation
Time frame: 5 to 7 days (visit #2)
Number of Participants With Intraocular Inflammation as seen on slit lamp and dilated fundus exam
1 secondary outcome
Number of Participants With Post Injection Pain Above 0 on a 11 Point Pain Scale.
Time frame: 24 to 48 hours visit #1 and 5 to 7 days visit #2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- 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.
Arshad Khanani, MD principal investigator
Sierra Eye Associates
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 0.3 mg and Aflibercept 2.0 mg in people with Diabetic Macular Edema, run by Arshad Khanani 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 6 inclusion and 10 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 26 Apr 2019. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2019). 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 Intraocular Inflammation (time frame: 24 to 48 hours (visit #1)). 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 26 Apr 2019.