Macular EdemaPhase 4NCT03261635
Ranibizumab Plus Indomethacin
A Phase 4 study testing Ranibizumab Injection and Indomethacin in people with Macular Edema, run by Università degli Studi di Brescia.
Trial summary
To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Ranibizumab Injection and Indomethacin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2016to 25 Jul 2017
- 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
- provision of written informed consent and compliance with study assessments for the full duration of the study
- age > 40 years
- presence of treatment-naïve neovascular AMD.
Who cannot join
- any previous intravitreal treatment
- previous laser treatment in the study eye
- myopia > 7 diopters in the study eye
- concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and 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 being investigated.
About this study
Official title: Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration
To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.
- Conditions
- Macular Edema
- Being tested
- Ranibizumab Injection, Indomethacin
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab InjectionDrug
patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
IndomethacinDrug
patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab Monotherapy | Active comparator | All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata Receives: Drug: Ranibizumab Injection |
| Ranibizumab + Indomethacin | Experimental | All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months. Receives: Drug: Ranibizumab Injection; Drug: Indomethacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central Retinal Thickness (microns)
Optical Coherence Tomography will be used to assess central retinal thickness.
Measured: 12-month
Visual Acuity (LogMAR)
ETDRS charts will be used to assess best corrected visual acuity
Measured: 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start7 Jan 2016
- Primary completion7 Dec 2016
- Study completion25 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
- Masking
- None (open label)
- Enrolment
- 58 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261635
- Sponsor's protocol ID
- NSAIDs_02
- Status last verified
- Aug 2017
- First submitted
- 20 Aug 2017
- Last updated
- 25 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Combination Ranibizumab and Indomethacin for Exudative Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT03261635
- Acronym / sponsor ID
- NSAIDs_02
- Conditions
- Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Università degli Studi di BresciaUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 7 Dec 2016 (actual)
- Study completion
- 25 Jul 2017 (actual)
- First posted
- 25 Aug 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.
To evaluate whether indomethacin eyedrops plus intravitreal ranibizumab (IVR) provides additional benefit over IVR monotherapy for treatment of choroidal neovascularization (CNV) in age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This was a prospective, randomized, pilot study in 58 patients with naï ve CNV. Patients were randomized 1:1 into 2 groups: ranibizumab monotherapy (RM group) and ranibizumab plus indomethacin (RI group). All patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. RI patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months.
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab Monotherapy | Active comparator | Drug: Ranibizumab InjectionAll patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata |
| Ranibizumab + Indomethacin | Experimental | Drug: Ranibizumab Injection, Drug: IndomethacinAll patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata. Moreover, patients also self- administered one drop of indomethacin three times a day for 12 months. All patients were followed up for 12 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- provision of written informed consent and compliance with study assessments for the full duration of the study
- age > 40 years
- presence of treatment-naïve neovascular AMD.
Key exclusion criteria (6 listed)
- any previous intravitreal treatment
- previous laser treatment in the study eye
- myopia > 7 diopters in the study eye
- concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy and 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 |
|---|---|---|
| Ranibizumab Injectionpatients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata | Drug | Ranibizumab + Indomethacin, Ranibizumab Monotherapy |
| Indomethacinpatients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months | Drug | Ranibizumab + Indomethacin |
Primary outcome
Central Retinal Thickness (microns)
Time frame: 12-month
Optical Coherence Tomography will be used to assess central retinal thickness.
Visual Acuity (LogMAR)
Time frame: 12-month
ETDRS charts will be used to assess best corrected visual acuity
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 25 Aug 2017.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab Injection and Indomethacin in people with Macular Edema, run by Università degli Studi di Brescia.
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 25 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Central Retinal Thickness (microns) (time frame: 12-month). 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 25 Aug 2017.