Proliferative Diabetic RetinopathyPhase 2NCT00907114
Topic Ketorolac Added to Panphotocoagulation in Proliferative Diabetic Retinopathy
A Phase 2 study testing Ketorolac tromethamine and Polivynilic alcohol in people with Proliferative Diabetic Retinopathy and Macular Edema, run by Hospital Juarez de Mexico at 1 site in Mexico.
Trial summary
The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Macular Edema
- What is being tested?
- Ketorolac tromethamine and Polivynilic alcohol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2009to Mar 2015
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- proliferative diabetic retinopathy
- without macular edema
- adequate quality 6 mm fast macular map on the day of treatment
- visual capacity under subjective refraction before treatment
- signed of inform consent
Who cannot join
- ocular surgery in the last 4 months
- myopia over -6.00 diopters
- allergy to ketorolac or non-steroids antiinflammatory
- previous selective photocoagulation
- using non-steroids antiinflammatory or immunomodulators
- intraocular inflammatory
Show all 13Show fewer
- any retinal disease different from diabetic retinopathy
- pregnancy
- actual corneal disease
- inadequate quality 6 mm fast macular map after the second visit
- inconsistency after the second visit
- adverse event of the drug
- remove of the inform consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
The purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.
Read the detailed description
Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.
Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.
- Conditions
- Proliferative Diabetic Retinopathy, Macular Edema
- Being tested
- Ketorolac tromethamine, Polivynilic alcohol
- Keywords
- proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketorolac tromethamineDrug
Also called Godek
Presentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation
Polivynilic alcoholDrug
Also called Acuafil
Presentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac tromethamine | Active comparator | ocular topic ketorolac used 4 times a day during a week after panphotocoagulation Receives: Drug: Ketorolac tromethamine |
| Polivynilic alcohol | Placebo comparator | ocular lubricant drops 4 times a day during one week after panphotocoagulation Receives: Drug: Polivynilic alcohol |
What is being measured
The primary outcome is the main question the study is designed to answer.
center subfield mean thickness using Stratus OCT measured in microns
Measured: baseline, 24, 48 and 168 hours after treatment
Secondary outcomes (2)
center point thickness using Stratus OCT, measured in microns
Measured: baseline, 24, 48 and 168 hours after treatment
macular volume using Stratus OCT, measured in cubic millimeters
Measured: baseline, 24, 48 and 168 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Juarez de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Virgilio Lima Gomez, Hospital Juarez de Mexico
- Investigators
- Virgilio Lima Gomez, MD, MSc, Study chair, Hospital Juarez de MexicoDulce M Razo Blanco Hernandez, MD, Principal investigator, Hospital Juarez de MexicoJuan Asbun Bojalil, MD, PhD, Study director, Hospital Juarez de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00907114
- Sponsor's protocol ID
- HJM 1667/09.03.24
- Status last verified
- Mar 2015
- First submitted
- 19 May 2009
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topic Ketorolac to Treat Center Point Thickness Secondary to Panphotocoagulation in Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT00907114
- Acronym / sponsor ID
- HJM 1667/09.03.24
- Conditions
- Proliferative Diabetic Retinopathy, Macular Edema
- Keywords
- proliferative diabetic retinopathy, macular edema, panphotocoagulation, topic ketorolac, efficacy, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- Jun 2009
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 May 2009 (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 purpose of this study is to determine the efficacy and safety of topic ketorolac in treatment for center point thickness secondary to panphotocoagulation in proliferative diabetic retinopathy.
Detailed description
Panphotocoagulation is the standard treatment for proliferative diabetic retinopathy during 3 to 4 sessions within 2 weeks. This treatment reduces the incidence of severe visual loss in the long term. Nonetheless, it induces macular thickness that delays the conclusion of the treatment. This delay could coincide with vitreous hemorrhage which, in turn, may limit additional photocoagulation.
Topic ketorolac could limit the inflammatory reaction cause by panphotocoagulation and produce early benefits in the patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac tromethamine | Active comparator | Drug: Ketorolac tromethamineocular topic ketorolac used 4 times a day during a week after panphotocoagulation |
| Polivynilic alcohol | Placebo comparator | Drug: Polivynilic alcoholocular lubricant drops 4 times a day during one week after panphotocoagulation |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- type 2 diabetes
- proliferative diabetic retinopathy
- without macular edema
- adequate quality 6 mm fast macular map on the day of treatment
- visual capacity under subjective refraction before treatment
Key exclusion criteria (13 listed)
- ocular surgery in the last 4 months
- myopia over -6.00 diopters
- allergy to ketorolac or non-steroids antiinflammatory
- previous selective photocoagulation
- using non-steroids antiinflammatory or immunomodulators
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 tromethamineAlso: GodekPresentation 5 mg/ml; Dosage: one drop (0.25 mg) four times a day during one week after panphotocoagulation | Drug | Ketorolac tromethamine |
| Polivynilic alcoholAlso: AcuafilPresentation: alcohol polivinilico 14 mg/ml; Dosage: one drop (0.7 mg alcohol polivinilico) four times a day during one week after panphotocoagulation | Drug | Polivynilic alcohol |
Primary outcome
center subfield mean thickness using Stratus OCT measured in microns
Time frame: baseline, 24, 48 and 168 hours after treatment
2 secondary outcomes
center point thickness using Stratus OCT, measured in microns
Time frame: baseline, 24, 48 and 168 hours after treatment
macular volume using Stratus OCT, measured in cubic millimeters
Time frame: baseline, 24, 48 and 168 hours after treatment
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 20 Mar 2015.
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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.
Virgilio Lima Gomez, MD, MSc study chair
Hospital Juarez de Mexico
Dulce M Razo Blanco Hernandez, MD principal investigator
Hospital Juarez de Mexico
Juan Asbun Bojalil, MD, PhD study director
Hospital Juarez de Mexico
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 Ketorolac tromethamine and Polivynilic alcohol in people with Proliferative Diabetic Retinopathy and Macular Edema, run by Hospital Juarez de Mexico at 1 site in Mexico.
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 13 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 20 Mar 2015. 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 Mexico. 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. Some participants in this study may receive a placebo. 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?
center subfield mean thickness using Stratus OCT measured in microns (time frame: baseline, 24, 48 and 168 hours after treatment). 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 20 Mar 2015.