Diabetic RetinopathyPhase 2NCT00900887
Topic Antiinflammatory Therapy Added to Selective Photocoagulation in Macular Edema
A Phase 2 study testing Ketorolac, Nepafenac and Polietilenglicol 400, propilenglicol in people with 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 of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- Ketorolac, Nepafenac and Polietilenglicol 400, propilenglicol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2008to 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- regardless of diabetes duration and retinopathy severity level
- one or both eyes with focal clinically significant macular edema
- treated with selective or focal photocoagulation
- visual capacity under subjective refraction before treatment
- adequate quality 6mm fast macular map on the day of photocoagulation
- signed of inform consent
Who cannot join
- ocular surgery in the last 4 months
- previous selective photocoagulation
- topic or systemic antiinflammatory therapy in the last week
- allergic to antiinflammatory non-steroids therapy
- lent contact used in tha last 2 days before photocoagulation
- history of ocular trauma, ocular infection or lacrimal dysfunction in the last 3 months
Show all 17Show fewer
- history of uveitis or ocular inflammation in the last 12 months
- any ocular external disease, infection or inflammatory process during evaluation
- corneal abnormalities that could modify visual capacity per se
- actual corneal disease
- pregnancy
- myopia over -6.00 diopters
- any retinal disease different from diabetic retinopathy
- adverse event of the drug
- desert to pharmacology therapy after the second visit
- no assistance after the second visit
- inadequate quality 6mm fast macular map after the second visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema
The purpose of this study is to determine the efficacy of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Read the detailed description
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- Ketorolac, Nepafenac, Polietilenglicol 400, propilenglicol
- Keywords
- diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called Godek
ophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week
NepafenacDrug
Also called Nevanac
topic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week
Polietilenglicol 400, propilenglicolDrug
Also called Systane
ocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml
dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Active comparator | ocular topic ketorolac used 3 times a day for a week after the selective photocoagulation Receives: Drug: Ketorolac |
| Nepafenac | Active comparator | ocular topic nepafenac 3 times a day during one week after selective photocoagulation Receives: Drug: Nepafenac |
| Polietilenglicol 400, propilenglicol | Placebo comparator | ocular lubricant drops 3 times a day for a week after selective photocoagulation Receives: Drug: Polietilenglicol 400, propilenglicol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
Measured: one week after treatment
Secondary outcomes (3)
center point thickness using stratus OCT measured in microns
Measured: before treatment, at 24, 48 and 168 hours after treatment
macular volume using stratus OCT measured in cubic millimeters
Measured: before treatment, 24, 48 and 168 hours after treatment
visual capacity under subjective refractive correction measured in decimal equivalent
Measured: before treatment, at 24, 48, 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 posted13 May 2009 (estimated)
- Study startApr 2008
- 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 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
- 84 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
- NCT00900887
- Sponsor's protocol ID
- HJM 1470/08.03.18
- Status last verified
- Mar 2015
- First submitted
- 11 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 of Topic Antiinflammatory Therapy Treatment in Center Point Thickness Secondary to Selective Photocoagulation in Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00900887
- Acronym / sponsor ID
- HJM 1470/08.03.18
- Conditions
- Diabetic Retinopathy, Macular Edema
- Keywords
- diabetic retinopathy, clinically significant macular edema, selective photocoagulation, topic ketorolac, topic nepafenac, efficacy, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hospital Juarez de MexicoOther government
- Study start
- Apr 2008
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 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 of ocular topic antiinflammatory therapy (sodic nepafenac at 0.1% or ketorolac at 0.5%) to treat center point thickness secondary to selective photocoagulation in diabetics with clinically significant macular edema.
Detailed description
Selective photocoagulation is the standard treatment for clinically significant macular edema. This treatment decreased the incidence of moderate visual loss in the long term. Nonetheless, in the first six weeks after treatment it is induced, probably because an exacerbation of macular edema secondary to treatment. An inflammatory response has been reported after selective photocoagulation. Therefore, antiinflammatory therapy like ketorolac or nepafenac could be useful to manage center point thickness secondary to selective photocoagulation in diabetics with macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Active comparator | Drug: Ketorolacocular topic ketorolac used 3 times a day for a week after the selective photocoagulation |
| Nepafenac | Active comparator | Drug: Nepafenacocular topic nepafenac 3 times a day during one week after selective photocoagulation |
| Polietilenglicol 400, propilenglicol | Placebo comparator | Drug: Polietilenglicol 400, propilenglicolocular lubricant drops 3 times a day for a week after selective photocoagulation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- type 2 diabetes
- regardless of diabetes duration and retinopathy severity level
- one or both eyes with focal clinically significant macular edema
- treated with selective or focal photocoagulation
- visual capacity under subjective refraction before treatment
Key exclusion criteria (17 listed)
- ocular surgery in the last 4 months
- previous selective photocoagulation
- topic or systemic antiinflammatory therapy in the last week
- allergic to antiinflammatory non-steroids therapy
- lent contact used in tha last 2 days before photocoagulation
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 |
|---|---|---|
| KetorolacAlso: Godekophthalmic presentation 5 mg/ml dosage one drop (0.25 mg) in the treated eye 3 times a day during one week | Drug | Ketorolac |
| NepafenacAlso: Nevanactopic presentation 1 mg/ml dosage one drop (0.05 mg) in the treated eye 3 times a day during one week | Drug | Nepafenac |
| Polietilenglicol 400, propilenglicolAlso: Systaneocular presentation Polietilenglicol 400 (4 mg), propilenglicol (3 mg), HP guar (1.9 mg)/1 ml dosage: one drop (0.2 mg polietinglicol 400, 0.15 mg propilenglicol, 0.095 mg HP guar) 3 times a day during one week | Drug | Polietilenglicol 400, propilenglicol |
Primary outcome
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation
Time frame: one week after treatment
3 secondary outcomes
center point thickness using stratus OCT measured in microns
Time frame: before treatment, at 24, 48 and 168 hours after treatment
macular volume using stratus OCT measured in cubic millimeters
Time frame: before treatment, 24, 48 and 168 hours after treatment
visual capacity under subjective refractive correction measured in decimal equivalent
Time frame: before treatment, at 24, 48, 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, Nepafenac and Polietilenglicol 400, propilenglicol in people with 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 7 inclusion and 17 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?
ocular topic antiinflammatory therapy (ketorolac, nepafenac or placebo) applied 3 times a day in the treated eye for a week after selective photocoagulation (time frame: one week 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.