Macular ThickeningPhase 2NEPAFNCT00801905
Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
A Phase 2 study testing Nepafenac and Lubricant in people with Macular Thickening and Macular Edema, run by Asociación para Evitar la Ceguera en México at 2 sites in Mexico.
Trial summary
The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Thickening, Macular Edema
- What is being tested?
- Nepafenac and Lubricant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesMexico
- Study dates
- Aug 2008to Mar 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Severe and proliferative Diabetic Retinopathy
- Symmetric severity grade on both eyes
- Best corrected visual acuity better than 20/80
Who cannot join
- Clinical significant macular edema
- Lens opacity
- Ocular surgery 6 months or less before recruit
- Uveitis history
- Actual use of topical or systemic non-steroidal anti inflammatory agents
- Actual or history of other macular diseases
Show all 10Show fewer
- Ocular surface diseases
- Vitreomacular traction syndrome
- Other vascular retinal diseases different to diabetic retinopathy
- Actual or history of use of topical prostaglandin analogues
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Asociación Para Evitar la Ceguera en México I.A.P.
Mexico City, 004030
Asociacion para Evitar la Ceguera en Mexico I.A.P.
Mexico City, 04030
About this study
The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.
Read the detailed description
Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.
- Conditions
- Macular Thickening, Macular Edema
- Being tested
- Nepafenac, Lubricant
- Keywords
- Macular thickening, Macular edema, Pan-retinal photocoagulation, Nepafenac, Topical non-steroidal anti inflammatory agents
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NepafenacDrug
Also called Nevanac 0.1%
Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed.
LubricantOther
Also called Systane
Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed
| Study group | Role | What they receive |
|---|---|---|
| 1: Nepafenac | Active comparator | Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed. Receives: Drug: Nepafenac |
| 2: placebo | Placebo comparator | Topical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed Receives: Other: Lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickening
Measured: 2 weeks after each laser session and 1 and 2 months after last laser session
Secondary outcomes (1)
Best corrected visual acuity
Measured: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startAug 2008
- Primary completionDec 2008
- Study completionMar 2009
Why it stopped: undefined
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular ThickeningStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dulce O Rascon-Vargas, Fellow, Principal investigator, Asociación Para Evitar la Ceguera en México I.A.P.Guadalupe Cervantes-Coste, Study chair, Asociación Para Evitar la Ceguera en México I.A.P.Jans Fromow-Guerra, Study director, Asociación Para Evitar la Ceguera en México I.A.P.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801905
- Sponsor's protocol ID
- NEPAFENAC IN PRFC
- Other IDs
- NEPAFENACO
- Acronym
- NEPAF
- Status last verified
- May 2024
- First submitted
- 3 Dec 2008
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Nepafenac in Macular Thickening Related to Pan-retinal Photocoagulation
- ClinicalTrials.gov ID
- NCT00801905
- Acronym / sponsor ID
- NEPAF / NEPAFENAC IN PRFC
- Conditions
- Macular Thickening, Macular Edema
- Keywords
- Macular thickening, Macular edema, Pan-retinal photocoagulation, Nepafenac, Topical non-steroidal anti inflammatory agents
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: undefined
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Aug 2008 (actual)
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Dec 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.
The purpose of this study is to determine whether topical nepafenac (qid) is effective in preventing and treating macular thickening related pan-retinal photocoagulation in patients with diabetic retinopathy.
Detailed description
Objective: To evaluate the effect of topical nepafenac 0.1 %, in preventing and in treating macular thickening related to pan-retinal photocoagulation in diabetic patients. Material and methods: This is a prospective, longitudinal, and controlled study in patients with diabetic retinopathy (severe non-proliferative and proliferative retinopathy), with a symmetric severity in both eyes and without a clinical significant macular edema. The best corrected visual acuity (BCVA) in all patients was 20/80 or better. All patients will undergo pan-retinal photocoagulation in three different sessions (with 2 weeks in apart between them). Each patient will receive topical nepafenac 0.1% (qid) on one eye, and placebo (qid) at the fellow eye, starting 1 week before the first retinal photocoagulation session and continued for 9 weeks ( ending 4 weeks after pan-retinal photocoagulation is completed). Spectral domain OCT and BCVA in ETDRS scale will be performed before and at 2 weeks after each laser session, and at 1, 2 and 3 months after treatment completed. BCVA and OCT outcomes of each studied period will be compared on both eyes, and side effects will be recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Nepafenac | Active comparator | Drug: NepafenacTopical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed. |
| 2: placebo | Placebo comparator | Other: LubricantTopical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Severe and proliferative Diabetic Retinopathy
- Symmetric severity grade on both eyes
- Best corrected visual acuity better than 20/80
Key exclusion criteria (10 listed)
- Clinical significant macular edema
- Lens opacity
- Ocular surgery 6 months or less before recruit
- Uveitis history
- Actual use of topical or systemic non-steroidal anti inflammatory agents
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 |
|---|---|---|
| NepafenacAlso: Nevanac 0.1%Topical nepafenac 0.1% is administrated every 6 hour 1 week before start pan-retinal photocoagulation and 4 weeks during all laser session performed biweekly, and 4 weeks after last laser sessión was completed. | Drug | 1: Nepafenac |
| LubricantAlso: SystaneTopical lubricating is administrated every 6 hours at fellow eye 1 week before start pan-retinal photocoagulation, 4 weeks during each laser session performed biweekly, and 4 weeks after last laser sessión was completed | Other | 2: placebo |
Primary outcome
Central macular thickening
Time frame: 2 weeks after each laser session and 1 and 2 months after last laser session
1 secondary outcome
Best corrected visual acuity
Time frame: 2 weeks after each laser session, 1, 2 and 3 months after pan-retinal photocoagulation is completed
Results and safety
The study was stopped early (reason given: undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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.
Dulce O Rascon-Vargas, Fellow principal investigator
Asociación Para Evitar la Ceguera en México I.A.P.
Guadalupe Cervantes-Coste study chair
Asociación Para Evitar la Ceguera en México I.A.P.
Jans Fromow-Guerra study director
Asociación Para Evitar la Ceguera en México I.A.P.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nepafenac and Lubricant in people with Macular Thickening and Macular Edema, run by Asociación para Evitar la Ceguera en México at 2 sites 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: undefined). Results are not available in the source record.
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 macular thickening (time frame: 2 weeks after each laser session and 1 and 2 months after last laser session). 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 30 May 2024.