Age-Related Macular DegenerationPhase 2NCT00805233
Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
A Phase 2 study testing combination ranibizumab + bromfenac and ranibizumab injection alone in people with Age-Related Macular Degeneration, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- combination ranibizumab + bromfenac and ranibizumab injection alone
- 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
- Dec 2008to Sep 2010
- 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
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Patients with active neovascular AMD
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
Who cannot join
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Current or recent participation in another simultaneous investigational drug trial may be exclusionary at the investigator's discretion
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- Previous intravitreal steroid or anti-VEGF therapy within last 3 months.
- Patients with a concurrent corneal epithelial disruption or erosion
- Patients with immune deficiencies that would affect the ability of the cornea to heal
- Patients with a known sensitivity to any component of the formulations under investigation
Trial locations and contacts
1 site in 1 country.
United States1 site
Casey Eye Institute at Oregon Health & Science University
Portland, Oregon, 97239
About this study
This open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone.
Read the detailed description
Age Related Macular Degeneration (AMD) is the leading cause of blindness in adults over the age of 50 years. It can cause permanent loss of eyesight due to deterioration of the macula.
Ranibizumab monotherapy is currently the standard of care in neovascular AMD patients. Inflammation is believed to play an important role in AMD. Currently, MD's are investigating modulating the inflammation component of AMD with intra-ocular steroids although there is a high rate of steroid associated adverse events, such as glaucoma, cataracts and endophthalmitis.
Bromfenac is a non-steroidal anti-inflammatory drug (NSAIDS) and is currently approved for the treatment of inflammation following cataract surgery. In combination with intravitreal ranibizumab, bromfenac may also provide anti-inflammatory effects and may be a safer alternative to steroids.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- combination ranibizumab + bromfenac, ranibizumab injection alone
- Keywords
- Neovascular, AMD, Treatment, Lucentis, Bromfenac
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination ranibizumab + bromfenacDrug
ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months. Plus one drop of bromfenac in the study eye twice per day, each day, for 12 months.
ranibizumab injection aloneDrug
ranibizumab injection in study eye each month for 4 months then as needed each month for 8 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Combination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops Receives: Drug: combination ranibizumab + bromfenac |
| 2 | Active comparator | ranibizumab injection alone. Receives: Drug: ranibizumab injection alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis
Measured: monthly
Secondary outcomes (1)
Mean change in visual acuity at 3, 6 and 12 months
Measured: every 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Investigators
- Peter J. Francis, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00805233
- Sponsor's protocol ID
- FVF4442
- Other IDs
- eIRB4543
- Status last verified
- Oct 2009
- First submitted
- 8 Dec 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Ranibizumab and Bromfenac for Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00805233
- Acronym / sponsor ID
- FVF4442
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Neovascular, AMD, Treatment, Lucentis, Bromfenac
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Dec 2008 (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 open-label, randomized, Phase II research study will look to see whether an investigational treatment combining bromfenac ophthalmic drops with ranibizumab intravitreal injection is safe and effective for treating wet AMD as compared to ranibizumab alone.
Detailed description
Age Related Macular Degeneration (AMD) is the leading cause of blindness in adults over the age of 50 years. It can cause permanent loss of eyesight due to deterioration of the macula.
Ranibizumab monotherapy is currently the standard of care in neovascular AMD patients. Inflammation is believed to play an important role in AMD. Currently, MD's are investigating modulating the inflammation component of AMD with intra-ocular steroids although there is a high rate of steroid associated adverse events, such as glaucoma, cataracts and endophthalmitis.
Bromfenac is a non-steroidal anti-inflammatory drug (NSAIDS) and is currently approved for the treatment of inflammation following cataract surgery. In combination with intravitreal ranibizumab, bromfenac may also provide anti-inflammatory effects and may be a safer alternative to steroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: combination ranibizumab + bromfenacCombination Ranibizumab intravitreal injection plus bromfenac ophthalmic drops |
| 2 | Active comparator | Drug: ranibizumab injection aloneranibizumab injection alone. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 50 years
- Patients with active neovascular AMD
- If the patient has bilateral disease and qualifies for the study, both eyes may be included
Key exclusion criteria (8 listed)
- Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Current or recent participation in another simultaneous investigational drug trial may be exclusionary at the investigator's discretion
- Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
- Previous intravitreal steroid or anti-VEGF therapy within last 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 |
|---|---|---|
| combination ranibizumab + bromfenacranibizumab injection in study eye each month for 4 months then as needed each month for 8 months. Plus one drop of bromfenac in the study eye twice per day, each day, for 12 months. | Drug | 1 |
| ranibizumab injection aloneranibizumab injection in study eye each month for 4 months then as needed each month for 8 months | Drug | 2 |
Primary outcome
Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis
Time frame: monthly
1 secondary outcome
Mean change in visual acuity at 3, 6 and 12 months
Time frame: every 3 months
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 Jul 2011.
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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.
Peter J. Francis, MD, PhD principal investigator
Oregon Health and Science University
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 combination ranibizumab + bromfenac and ranibizumab injection alone in people with Age-Related Macular Degeneration, run by Oregon Health and Science University 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 4 inclusion and 8 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 Jul 2011. 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?
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?
Assessment of ocular adverse events, including uncontrolled inflammation, endophthalmitis, and retinal tear/detachment, abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis (time frame: monthly). 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 Jul 2011.