DMEPhase 2/3NCT04119921
Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
A Phase 2/3 study testing prescription topical ketorolac in group 1, prescription artificial tear in group 2 and prescription topical ketorolac in group 2 in people with DME, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB). Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- DME
- What is being tested?
- prescription topical ketorolac in group 1, prescription artificial tear in group 2 and prescription topical ketorolac in group 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2018to 20 Jun 2020
- Phase
- Phase 2/3
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BCVA≤20/40 and BCVA 20/400 and better
- History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
- Requires 2 IVB in the next 12 weeks
- Macular thickness >300 μm
- NO Other eye diseases
- Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
Who cannot join
- hgb A1c> 8
- high risk PDR
- Macular edema due to a cause other than diabetic retinopathy
- Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
- Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
- History of macular photocoagulation during the last 6 months
Show all 11Show fewer
- intraocular surgery(except cataract surgery)
- Cataract extractionin less than 6 months ago
- Uveitis ,NVG ,exudative AMD, HR PDR.
- Uncontrolled glaucoma
- Vitreomacular traction or epiretinal membrane
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB).
Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.
- Conditions
- DME
- Being tested
- prescription topical ketorolac in group 1, prescription artificial tear in group 2, prescription topical ketorolac in group 2, prescription artificial tear in group1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prescription topical ketorolac in group 1Drug
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
prescription artificial tear in group 2Drug
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
prescription topical ketorolac in group 2Drug
artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
prescription artificial tear in group1Drug
topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
| Study group | Role | What they receive |
|---|---|---|
| usage of topical ketorolac in group1 | Active comparator | usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. Receives: Drug: prescription topical ketorolac in group 1 |
| usage of artificial tear in group 2 | Active comparator | usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. Receives: Drug: prescription artificial tear in group 2 |
| usage of artificial tear in group 1 | Active comparator | usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval Receives: Drug: prescription artificial tear in group1 |
| usage of topical ketorolac in group2 | Active comparator | usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval Receives: Drug: prescription topical ketorolac in group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Snellen E-chart
Measured: 6 weeks
Secondary outcomes (1)
Centeral macular thickness
Ophtical Cohearence Tomography
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start1 Jan 2018
- Primary completion1 Jun 2018
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMEStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119921
- Sponsor's protocol ID
- 97377
- Status last verified
- Oct 2019
- First submitted
- 2 Oct 2019
- Last updated
- 23 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
- ClinicalTrials.gov ID
- NCT04119921
- Acronym / sponsor ID
- 97377
- Conditions
- DME
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 9 Oct 2019 (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.
Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB).
Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| usage of topical ketorolac in group1 | Active comparator | Drug: prescription topical ketorolac in group 1usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. |
| usage of artificial tear in group 2 | Active comparator | Drug: prescription artificial tear in group 2usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. |
| usage of artificial tear in group 1 | Active comparator | Drug: prescription artificial tear in group1usage of topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval |
| usage of topical ketorolac in group2 | Active comparator | Drug: prescription topical ketorolac in group 2usage of artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- BCVA≤20/40 and BCVA 20/400 and better
- History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months
- Requires 2 IVB in the next 12 weeks
- Macular thickness >300 μm
- NO Other eye diseases
Key exclusion criteria (11 listed)
- hgb A1c> 8
- high risk PDR
- Macular edema due to a cause other than diabetic retinopathy
- Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)
- Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months
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 |
|---|---|---|
| prescription topical ketorolac in group 1topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. | Drug | usage of topical ketorolac in group1 |
| prescription artificial tear in group 2artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. | Drug | usage of artificial tear in group 2 |
| prescription topical ketorolac in group 2artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval. | Drug | usage of topical ketorolac in group2 |
| prescription artificial tear in group1topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. | Drug | usage of artificial tear in group 1 |
Primary outcome
visual acuity
Time frame: 6 weeks
Snellen E-chart
1 secondary outcome
Centeral macular thickness
Time frame: 6 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 23 Feb 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prescription topical ketorolac in group 1, prescription artificial tear in group 2 and prescription topical ketorolac in group 2 in people with DME, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 11 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 23 Feb 2021. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
visual acuity (time frame: 6 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 23 Feb 2021.