Wet Macular DegenerationPhase 4NCT02060604
Pilot Study of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
A Phase 4 study testing Ketorolac + Ranibizumab and Ranibizumab in people with Wet Macular Degeneration, run by Università degli Studi di Brescia at 1 site in Italy.
Trial summary
The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Wet Macular Degeneration
- What is being tested?
- Ketorolac + Ranibizumab and Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2012to Jan 2014
- Phase
- Phase 4
- 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 40 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 >40 years;
- presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.
Who cannot join
- any previous intravitreal treatment;
- previous laser treatment in the study eye;
- myopia >7 dioptres in the study eye;
- concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
- concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
- known sensitivity to any component of the formulations under investigation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.
- Conditions
- Wet Macular Degeneration
- Being tested
- Ketorolac + Ranibizumab, Ranibizumab
- Keywords
- ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization
- Medical subject headings
- Wet Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac + RanibizumabDrug
3 monthly ranibizumab, then as needed Ketorolac TID
RanibizumabDrug
3 monthly ranibizumab, then as needed
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac + Ranibizumab | Experimental | 3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID Receives: Drug: Ketorolac + Ranibizumab |
| Ranibizumab Alone | Active comparator | 3 monthly ranibizumab, then as needed Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
Measured: 12 months
Secondary outcomes (3)
mean change in central macular thickness
Measured: 12 months
mean number of intravitreal injections over the 12-month period
Measured: 12 months
adverse ocular events at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Russo, Università degli Studi di Brescia
- Investigators
- Andrea Russo, MD, Principal investigator, University of Brescia, ItalyLuisa Delcassi, MD, Study chair, University of Brescia, ItalyFrancesco Semeraro, Professor, Study director, University of Brescia, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060604
- Sponsor's protocol ID
- NSAIDs_01
- Status last verified
- Feb 2014
- First submitted
- 8 Feb 2014
- Last updated
- 12 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Ranibizumab With and Without Ketorolac Eyedrops for Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02060604
- Acronym / sponsor ID
- NSAIDs_01
- Conditions
- Wet Macular Degeneration
- Keywords
- ketorolac, NSAIDs, wet macular degeneration, choroidal neovascularization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Feb 2014 (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.
The addition of an anti-inflammatory agent could be a valid option for controlling choroidal neovascularization, as simply inhibiting VEGF addresses neither the multifactorial pathogenesis of choroidal neovascularization nor the underlying cause of VEGF production.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac + Ranibizumab | Experimental | Drug: Ketorolac + Ranibizumab3 monthly ranibizumab, then as needed plus ketorolac eyedrops TID |
| Ranibizumab Alone | Active comparator | Drug: Ranibizumab3 monthly ranibizumab, then as needed |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ability to provide written informed consent and comply with study assessments for the full duration of the study;
- age >40 years;
- presence of treatment-naïve neovascular AMD with a visual acuity between 20/25 and 20/200 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Inclusion criteria for AMD were neovascularisation, fluid, or haemorrhage under the fovea.
Key exclusion criteria (6 listed)
- any previous intravitreal treatment;
- previous laser treatment in the study eye;
- myopia >7 dioptres in the study eye;
- concurrent eye disease in the study eye that could compromise visual acuity (eg, diabetic retinopathy, advanced glaucoma);
- concurrent corneal epithelial disruption or any condition that would affect the ability of the cornea to heal;
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 |
|---|---|---|
| Ketorolac + Ranibizumab3 monthly ranibizumab, then as needed Ketorolac TID | Drug | Ketorolac + Ranibizumab |
| Ranibizumab3 monthly ranibizumab, then as needed | Drug | Ranibizumab Alone |
Primary outcome
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score
Time frame: 12 months
3 secondary outcomes
mean change in central macular thickness
Time frame: 12 months
mean number of intravitreal injections over the 12-month period
Time frame: 12 months
adverse ocular events at 12 months
Time frame: 12 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 12 Feb 2014.
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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.
Andrea Russo, MD principal investigator
University of Brescia, Italy
Luisa Delcassi, MD study chair
University of Brescia, Italy
Francesco Semeraro, Professor study director
University of Brescia, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketorolac + Ranibizumab and Ranibizumab in people with Wet Macular Degeneration, run by Università degli Studi di Brescia at 1 site in Italy.
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 3 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 12 Feb 2014. 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 Italy. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
mean change in study eye visual acuity as measured by the best-corrected ETDRS letter score (time frame: 12 months). 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 12 Feb 2014.