Diabetic Macular EdemaPhase 3NEVANACNCT00780780
Efficacy Study of Triamcinolone Associated With Nepafenac for Treatment of Diabetic Macular Edema
A Phase 3 study testing Triamcinolone + Nepafenac and triamcinolone intravitreal injection in people with Diabetic Macular Edema, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Diabetics retinopathy remains the major threat to sight in the working age population in the developed world. Furthermore, it is increasing as a major cause of blindness in other parts of the world, especially developing countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Triamcinolone + Nepafenac and triamcinolone intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Oct 2012
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age at least
- Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:
- current regular use of insulin for the treatment of diabetes
- current regular use of oral hypoglycemic agents for the treatment of diabetes diabetes as defined by american Diabetes Association (ADA)
- symptoms of diabetes (polyuria, polydipsia, and unexplained weight loss) or eigth-hour fasting plasma glucose > 126 mg/dl
- Diabetic macular edema clinically observable associated with diabetic retinopathy:
Show all 10Show fewer
- prior treated with any treatment or one or three sessions focal laser or grid for DME, intervals between sessions must be at least 30 days
- the most recent laser at least 3 months prior to Baseline, or no prior medical therapy for diabetic macular edema, or in the investigator opinion the patient would not benefit from macular laser treatment, or the patient refuses laser treatments
- BCVA score between 34 letters (20/320 ETDRS)e 68 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
- Retinal thickness > 250 um by OCT
Who cannot join
- Uncontrolled systemic disease
- Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
- Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
- Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15 letters improvement of visual acuity (e.g. severe macular ischemia)
- Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
- Presence of an epiretinal membrane in the study eye
Show all 31Show fewer
- History of IOP elevation in response to steroid treatment in either eye
- History of glaucoma or optic nerve head change consistent with glaucoma damage, and/or glaucomatous visual field loss in the study eye
- Ocular hypertension in the study eye requiring more than 1 anti-glaucoma medication to maintain IOP < 22mmHg at qualification visit
- Presence of anterior chamber intraocular lens in the study eye
- Active optic disc or retinal neovascularization in the study eye at qualification visit
- Active or history of choroidal neovascularization in the study eye
- Presence of rubeosis irides in the study eye at qualification visit
- Any active ocular infection (i.e. bacterial, viral, parasitic or fungal) in qualification
- History of herpetic infection in the study eye or adnexa
- Presence of active or inactive toxoplasmosis in either eye at qualification
- Presence of visible scleral thinning or ectasia in the study eye
- Media opacity in the study eye at qualification
- Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 90 days prior to qualification.
- History of central serous chorioretinopathy in either eye
- History of pars plana vitrectomy in the study eye
- History of use of intravitreal steroids in the study eye within 3 months prior qualification
- Periocular depot of steroids to the study eye with 3 months prior to qualification
- Use of systemic steroids within 1 month prior qualification or anticipated use at any time during the study
- Use of inhibitors of carbonic anhydrase within 1 month prior qualification or anticipated use at any time during the study
- Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents with 6 months prior to qualification or anticipated use at any time during the study
- BCVA < 34 letters (20/200 snellen equivalent) in the non-study eye using the ETDRS at qualification
- Known allergy of hypersensitivity to the study medication or its components
- Known allergy or contraindication to the use of fluorescein or povidone iodine
- Contraindication to pupil dilation in either eye
- Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Sao Paulo - Dept. of Ophthalmology / Vision Institute
São Paulo, São Paulo, 04023062
About this study
Official title: A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema
Diabetics retinopathy remains the major threat to sight in the working age population in the developed world. Furthermore, it is increasing as a major cause of blindness in other parts of the world, especially developing countries. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision.
The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic macular edema and it is considered an important treatment since it improves the visual acuity of patients with resolution of edema.
Read more
Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat ocular posterior segment inflammation.
The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated with nepafenac eye drops as treatment of diabetic macular edema.
Read the detailed description
We plan to enroll 40 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and OCT (OCT Stratus - Zeiss)in both eyes in following visits: Baseline, Week 4, 8, 12, 20 and 25. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. The patients will be evaluated during 25 weeks (7 visits). Parameters for clinical evaluation: visual acuity, IOP, biomicroscopy, fundus examination through dilated pupil and OCT.
Group A: 20 patients will receive intravitreal triamcinolone injection Group B: 20 patients will receive intravitreal triamcinolone injection associated with nepafenac eye drops (1 gtt, tid) during 6 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- Triamcinolone + Nepafenac, triamcinolone intravitreal injection
- Keywords
- triamcinolone, nepafenac, DME, edema macular
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone + NepafenacDrug
Also called Nepafenac (Nevanac)
Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months
triamcinolone intravitreal injectionDrug
Also called triamcinolone
triamcinolone intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Triamcinolone intravitreal injection + Nepafenac eye drops Receives: Drug: Triamcinolone + Nepafenac |
| 2 | Other | Triamcinolone intravitreal injection Receives: Drug: triamcinolone intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Measured: Weeks 1, 4, 8, 12, 20 and 25
Optical coherence tomography (OCT)
Measured: Weeks 4, 8, 12, 20 and 25
Secondary outcomes (1)
Biomicroscopy/Fundus examination
Measured: Day 1, Weeks: 1, 4, 8, 12, 20 and 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rubens Belfort Jr, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780780
- Sponsor's protocol ID
- CEP 0754/07
- Acronym
- NEVANAC
- Status last verified
- Aug 2012
- First submitted
- 27 Oct 2008
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Parallel, Masked to Evaluate the Efficacy of Triamcinolone Associated With Nepafenac (Nevanac) Compared With Intravitreal Injection of Triamcinolone for Treatment of Clinically Significant Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00780780
- Acronym / sponsor ID
- NEVANAC / CEP 0754/07
- Conditions
- Diabetic Macular Edema
- Keywords
- triamcinolone, nepafenac, DME, edema macular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Aug 2008 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Oct 2008 (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.
Diabetics retinopathy remains the major threat to sight in the working age population in the developed world. Furthermore, it is increasing as a major cause of blindness in other parts of the world, especially developing countries. Diabetic macular edema (DME) is a manifestation of diabetic retinopathy that produces loss of central vision.
The triamcinolone intravitreal injection (1-4mg) is indicated to treatment of diabetic macular edema and it is considered an important treatment since it improves the visual acuity of patients with resolution of edema.
Nepafenac is a non-steroidal anti-inflammatory drug (NSAID), usually sold as a prescription eye drop (0.1% solution). Nepafenac is manufactured by Alcon as Nevanac. It is approved by FDA as well as ANVISA. Pre-clinical studies suggest this medication showed efficacy to treat ocular posterior segment inflammation.
The purpose of this study is evaluate the efficacy of intravitreal triamcinolone associated with nepafenac eye drops as treatment of diabetic macular edema.
Detailed description
We plan to enroll 40 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and OCT (OCT Stratus - Zeiss)in both eyes in following visits: Baseline, Week 4, 8, 12, 20 and 25. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. The patients will be evaluated during 25 weeks (7 visits). Parameters for clinical evaluation: visual acuity, IOP, biomicroscopy, fundus examination through dilated pupil and OCT.
Group A: 20 patients will receive intravitreal triamcinolone injection Group B: 20 patients will receive intravitreal triamcinolone injection associated with nepafenac eye drops (1 gtt, tid) during 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Triamcinolone + NepafenacTriamcinolone intravitreal injection + Nepafenac eye drops |
| 2 | Other | Drug: triamcinolone intravitreal injectionTriamcinolone intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years of age at least
- Diagnosis of diabetes mellitus (type 1 or type 2. any one of the following will be considered to be sufficient evidence that diabetes is present:
- Diabetic macular edema clinically observable associated with diabetic retinopathy:
- BCVA score between 34 letters (20/320 ETDRS)e 68 letters (20/40 ETDRS) in the study eye measured by the ETDRS method at qualification/baseline visit
- Retinal thickness > 250 um by OCT
Key exclusion criteria (31 listed)
- Uncontrolled systemic disease
- Initiation of medical therapy for diabetes or a change from oral hypoglycemic agents to insulin therapy within 4 months prior to the qualification visit
- Renal failure requiring hemodialysis or peritoneal dialysis within 6 months prior to the qualification visit
- Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15 letters improvement of visual acuity (e.g. severe macular ischemia)
- Presence of branch retinal vein occlusion, central retinal vein occlusion, uveitis, pseudophakic cystoid edema or any other condition in the study eye which could be contributing to macular edema
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 |
|---|---|---|
| Triamcinolone + NepafenacAlso: Nepafenac (Nevanac)Triamcinolone intravitreal injection 0,1 ml (4mg) Nepafenac 1 drop, tid, during 6 months | Drug | 1 |
| triamcinolone intravitreal injectionAlso: triamcinolonetriamcinolone intravitreal injection | Drug | 2 |
Primary outcome
Visual acuity
Time frame: Weeks 1, 4, 8, 12, 20 and 25
Optical coherence tomography (OCT)
Time frame: Weeks 4, 8, 12, 20 and 25
1 secondary outcome
Biomicroscopy/Fundus examination
Time frame: Day 1, Weeks: 1, 4, 8, 12, 20 and 25
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 2018.
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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.
Rubens Belfort Jr, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone + Nepafenac and triamcinolone intravitreal injection in people with Diabetic Macular Edema, run by Federal University of São Paulo at 1 site in Brazil.
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 10 inclusion and 31 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 2018. 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 Brazil. 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 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: Weeks 1, 4, 8, 12, 20 and 25). 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 20 Mar 2018.