Neovascular Age-Related Macular DegenerationPhase 1/2NCT01926977
Evaluation of Pain and Inflammation After Injection of Lucentis vs Eylea for Treatment of Wet Macular Degeneration
A Phase 1/2 study testing Ranibizumab 0.5mg and Aflibercept 2.0mg in people with Neovascular Age-Related Macular Degeneration, 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 vs Aflibercept. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- Ranibizumab 0.5mg and Aflibercept 2.0mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to May 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to provide informed consent and comply with study assessments for the full duration of the study
- Age >/= 65 years
- New onset Neovascular Age-Related Macular Degeneration or (See No.4)
- Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
- Visual Acuity of 20/400 or better
- No history of Post injection pain or inflammation with prior treatments -
Who cannot join
- History of Endophthalmitis in either eye
- Uncontrolled or symptomatic Dry Eye Syndrome
- History of Anterior or Posterior Uveitis
- History of Post injection pain or inflammation 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 Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
This study is designed to compare the post injection inflammation and pain seen after intravitreal injections of Ranibizumab vs Aflibercept.
Read the detailed description
This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).
The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber 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 Nomenclature (SUN) working group classifications.
Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.
- Being tested
- Ranibizumab 0.5mg, Aflibercept 2.0mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.5mgDrug
Also called Lucentis
Patient will receive intravitreal injection of Ranibizumab 0.5mg.
Aflibercept 2.0mgDrug
Also called Eylea
Patients will receive intravitreal injection of Aflibercept 2.0mg.
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5mg Intravitreal injection | Active comparator | Intravitreal injection of Ranibizumab 0.5mg once Receives: Drug: Ranibizumab 0.5mg |
| Aflibercept 2.0mg Intravitreal injection | Active comparator | Intravitreal Aflibercept 2.0mg once Receives: Drug: Aflibercept 2.0mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of Anterior Chamber Inflammation
Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
Measured: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Secondary outcomes (1)
Patients With Post Injection Pain Score of One or Higher on Pain Scale
Pain score rated on an 11 point numerical rating from 0-10 ( 0 = no pain, and 10 = worst possible pain) administered to each patient verbally at visit #1 and visit #2. The data below shows number of patients with pain score 1 or greater in each group.
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 posted21 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 2014
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 Neovascular Age-Related Macular DegenerationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 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 M Khanani, MD, Principal investigator, Sierra Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926977
- Sponsor's protocol ID
- ML28895
- Other IDs
- 20131227
- Status last verified
- Feb 2016
- First submitted
- 19 Aug 2013
- Last updated
- 3 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Injection Inflammation and Pain After Ranibizumab vs Aflibercept Intravitreal Injections
- ClinicalTrials.gov ID
- NCT01926977
- Acronym / sponsor ID
- ML28895
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Arshad KhananiUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Posted 3 Mar 2016
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 vs Aflibercept.
Detailed description
This is an open-label, Phase I-II study of post injection pain and inflammation after intravitreally administered Ranibizumab and Aflibercept in 100 subjects with Neovascular Age-Related Macular Degeneration. We will enroll both treatment experienced ( patients who were treated with Lucentis or Eylea, but not Avastin in the past) and treatment naive patients ( new onset Neovascular AMD with no history of intravitreal injections).
The treatment experienced patients will be treated with the intravitreal medication other than what they were receiving in the past, for example, patients treated with Lucentis will switch to Eylea for study purposes and vice versa.
Consented, enrolled subjects will receive open-label intravitreal injection of either 0.5mg Ranibizumab or 2mg Aflibercept. A standard intravitreal injection protocol will be followed. Patients will be reevaluated between 24-48 hours and 5-7 days post injections. A non-injecting physician will evaluate the patients for anterior chamber 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 Nomenclature (SUN) working group classifications.
Pain score will be evaluated using a Numerical Rating Scale. Each patient will have a standard script verbally read to them at their visit, and asked to rate their pain based on this scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5mg Intravitreal injection | Active comparator | Drug: Ranibizumab 0.5mgIntravitreal injection of Ranibizumab 0.5mg once |
| Aflibercept 2.0mg Intravitreal injection | Active comparator | Drug: Aflibercept 2.0mgIntravitreal Aflibercept 2.0mg once |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Able to provide informed consent and comply with study assessments for the full duration of the study
- Age >/= 65 years
- New onset Neovascular Age-Related Macular Degeneration or (See No.4)
- Previously treated Neovascular Age-Related Macular Degeneration with Lucentis or Eylea intravitreal injections
- Visual Acuity of 20/400 or better
Key exclusion criteria (6 listed)
- History of Endophthalmitis in either eye
- Uncontrolled or symptomatic Dry Eye Syndrome
- History of Anterior or Posterior Uveitis
- History of Post injection pain or inflammation with prior treatments
- Recent thromboembolic event(<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 0.5mgAlso: LucentisPatient will receive intravitreal injection of Ranibizumab 0.5mg. | Drug | Ranibizumab 0.5mg Intravitreal injection |
| Aflibercept 2.0mgAlso: EyleaPatients will receive intravitreal injection of Aflibercept 2.0mg. | Drug | Aflibercept 2.0mg Intravitreal injection |
Primary outcome
Evidence of Anterior Chamber Inflammation
Time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)
Evidence of anterior chamber inflammation at visit #1 and #2 using Standardization of Uveitis Nomenclature (SUN)
1 secondary outcome
Patients With Post Injection Pain Score of One or Higher on 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 3 Mar 2016.
- 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 M 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 1/2 study testing Ranibizumab 0.5mg and Aflibercept 2.0mg in people with Neovascular Age-Related Macular Degeneration, 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 6 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 Mar 2016. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2016). 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?
Evidence of Anterior Chamber Inflammation (time frame: 24 to 48 hours (visit #1) and 5 to 7 days (visit #2)). 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 Mar 2016.