Exudative Age Related Macular DegenerationPhase 2NCT03071055
Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF
A Phase 2 study testing Ranibizumab Injection [Lucentis] in people with Exudative Age Related Macular Degeneration, run by Southeast Clinical Research Associates, LLC at 2 sites in United States.
Trial summary
This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Exudative Age Related Macular Degeneration
- What is being tested?
- Ranibizumab Injection [Lucentis]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2017to 3 Jun 2019
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50 years
- Exudative age related macular degeneration in study eye involving the fovea
- Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)
- Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
- At least 30 days from last intravitreal anti-VEGF injection in the study eye
Who cannot join
- Patient who are receiving systemic anti-VEGF or proangiogenic therapy
- Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)
- Patients on chronic immunosuppressant therapy
- Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
- History of intravitreal corticosteroids in study eye within 4 months of baseline
- Uncontrolled hypertension (defined as systolic >180 mm Hg and/or diastolic > 100 mm Hg while patient is sitting)
Show all 12Show fewer
- History of stroke or APTC event in the previous year
- Any intraocular surgery in study eye within 90 days of baseline
- Presence of vitreomacular traction in study eye
- Presence of significant epiretinal proliferation in study eye
- Evidence of active infection in either eye
- Uncontrolled glaucoma in the study eye defined as a pressure > 25 mmHg on maximal medical therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210
Charlotte Eye Ear Nose and Throat Associates, PA
Statesville, North Carolina, 28677
About this study
Official title: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe
This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
Read the detailed description
This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.
Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.
- Being tested
- Ranibizumab Injection [Lucentis]
- Keywords
- Macular Degeneration, AMD, Wet AMD, Lucentis
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab Injection [Lucentis]Drug
Also called Lucentis
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| ranibizumab | Active comparator | ranibizumab 0.5mg in commercially available vial Receives: Drug: Ranibizumab Injection [Lucentis] |
| ranibizumab pre filled-syringe | Experimental | ranibizumab 0.5mg in soon to be available pre-filled syringe Receives: Drug: Ranibizumab Injection [Lucentis] |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is mean change in ETDRS BCVA visual acuity
The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.
Measured: 24 weeks
Secondary outcomes (6)
Proportion of eyes that gain or lose >0 letters at 24 weeks
Proportion of eyes that gain or lose >0 letters at 24 weeks
Measured: 24 weeks
Proportion of eyes that gain or lose > 5 letters at 24 weeks
Proportion of eyes that gain or lose > 5 letters at 24 weeks
Measured: 24 weeks
Proportion of eyes that gain or lose > 10 letters at 24 weeks
Proportion of eyes that gain or lose > 10 letters at 24 weeks
Measured: 24 weeks
Proportion of eyes that gain or lose > 15 letters at 24 weeks
Proportion of eyes that gain or lose > 15 letters at 24 weeks
Measured: 24 weeks
To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
Measured: 24 weeks
• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
- Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
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 posted6 Mar 2017
- Study start1 Oct 2017
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exudative 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast Clinical Research Associates, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Andrew N. Antoszyk, MD, Southeast Clinical Research Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071055
- Sponsor's protocol ID
- ML29459
- Status last verified
- Oct 2020
- First submitted
- 24 Feb 2017
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe
- ClinicalTrials.gov ID
- NCT03071055
- Acronym / sponsor ID
- ML29459
- Keywords
- Macular Degeneration, AMD, Wet AMD, Lucentis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Southeast Clinical Research Associates, LLCUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 6 Mar 2017 (actual)
- 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 a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.
Detailed description
This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.
Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.
Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ranibizumab | Active comparator | Drug: Ranibizumab Injection [Lucentis]ranibizumab 0.5mg in commercially available vial |
| ranibizumab pre filled-syringe | Experimental | Drug: Ranibizumab Injection [Lucentis]ranibizumab 0.5mg in soon to be available pre-filled syringe |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 50 years
- Exudative age related macular degeneration in study eye involving the fovea
- Best Corrected Visual Acuity (by ETDRS) letter score in study eye of < 85 and > 24 (approximate Snellen equivalent 20/20 to 20/320)
- Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
- At least 30 days from last intravitreal anti-VEGF injection in the study eye
Key exclusion criteria (12 listed)
- Patient who are receiving systemic anti-VEGF or proangiogenic therapy
- Patients on chronic high doses corticosteroid therapy (> than 10 mg of oral prednisone or equivalent greater than 10 days)
- Patients on chronic immunosuppressant therapy
- Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
- History of intravitreal corticosteroids in study eye within 4 months of baseline
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 Injection [Lucentis]Also: Lucentisintravitreal injection | Drug | ranibizumab, ranibizumab pre filled-syringe |
Primary outcome
The primary outcome measure is mean change in ETDRS BCVA visual acuity
Time frame: 24 weeks
The primary outcome measure is mean change in ETDRS BCVA visual acuity at 24 weeks compared to baseline.
6 secondary outcomes
Proportion of eyes that gain or lose >0 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 5 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 10 letters at 24 weeks
Time frame: 24 weeks
Proportion of eyes that gain or lose > 15 letters at 24 weeks
Time frame: 24 weeks
To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
Time frame: 24 weeks
• Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Injection [Lucentis] in people with Exudative Age Related Macular Degeneration, run by Southeast Clinical Research Associates, LLC 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 5 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: finished, as of the sponsor's last update on 22 Oct 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome measure is mean change in ETDRS BCVA visual acuity (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 22 Oct 2020.