Proliferative Diabetic RetinopathyPhase 2NCT01389505
Bevacizumab as Adjunctive Treatment to Laser Panretinal Photocoagulation for Proliferative Diabetic Retinopathy
A Phase 2 study testing Panretinal photocoagulation and Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab in people with Proliferative Diabetic Retinopathy, run by Instituto do Coracao at 1 site in Brazil.
Trial summary
This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Panretinal photocoagulation and Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Sep 2012
- 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
- Proliferative diabetic retinopathy eyes.
- Best Corrected-Visual Acuity at baseline > 20/320 in the study eye.
- Patients with and without diabetic macular edema
- Type II diabetic subjects as defined by the World Health Organization
- aged ≥ 18 years.
- Women must be using effective contraception
- Ability to provide written informed consent.
- Indication of panretinal photocoagulation in both eyes
Who cannot join
- Vitreous hemorrhage or pre-retinal hemorrhage
- Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
- Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- Cataract
- Any intraocular surgery within 6 months before trial enrollment.
- Previous vitrectomy.
- Any of the following underlying systemic diseases:
- History or evidence of severe cardiac disease or previous thrombus-embolic event
Trial locations and contacts
1 site in 1 country.
University Sao Paulo contact
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo
São Paulo, São Paulo, 05403-000
Rony C Preti, MD, +551199991636, rypreti@hotmail.com
Rony C Preti, MD
About this study
Official title: Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)
This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The patients with proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity and contrast sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one, three and six months after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients.
Read the detailed description
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal Bevacizumab plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity and contrast vision measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.
Patients with similar proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and intravitreal Bevacizumab injections in one eye. For the Bevacizumab injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Panretinal photocoagulation, Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab
- Keywords
- Proliferative Diabetic Retinopathy, Bevacizumab, Panretinal Photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal photocoagulationProcedure or surgery
Three episodes of panretinal photocoagulation with one week of interval
Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of BevacizumabProcedure or surgery
Intravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP
| Study group | Role | What they receive |
|---|---|---|
| Panretinal photocoagulation | Active comparator | Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3. Receives: Procedure: Panretinal photocoagulation |
| Bevacizumab + Panretinal Photocoagulation (PRP) | Experimental | Group 2: Bevacizumab intravitreous injections plus PRP Receives: Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Macular Evaluation
During this 24 weeks of follow-up the Visual acuity (ETDRS), Contrast vision will be measured at baseline, 4, 12 and finally at 24 week
Measured: 24 weeks
Secondary outcomes (1)
Structural Macular Evaluation
During the 24 weeks of follow-up the following measured will be made: Optical coherence tomography, need of vitrectomy, need panretianal photocoagulation retreatment, adverse events, recurrence of neovascularizaton, need or additional focal and grid macular laser for diabetic macular edema
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Coracao
- Sponsor type
- Other government
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Investigators
- Walter Y Takahashi, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389505
- Sponsor's protocol ID
- CONEP16249
- Other IDs
- CONEP16249
- Status last verified
- Jan 2011
- First submitted
- 5 Jul 2011
- Last updated
- 8 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Preti RC, Mutti A, Ferraz DA, Zacharias LC, Nakashima Y, Takahashi WY, Monteiro ML. The effect of laser pan-retinal photocoagulation with or without intravitreal bevacizumab injections on the OCT-measured macular choroidal thickness of eyes with proliferative diabetic retinopathy. Clinics (Sao Paulo). 2017 Feb 1;72(2):81-86. doi: 10.6061/clinics/2017(02)03.
PubMed 28273240Preti RC, Ramirez LM, Monteiro ML, Carra MK, Pelayes DE, Takahashi WY. Contrast sensitivity evaluation in high risk proliferative diabetic retinopathy treated with panretinal photocoagulation associated or not with intravitreal bevacizumab injections: a randomised clinical trial. Br J Ophthalmol. 2013 Jul;97(7):885-9. doi: 10.1136/bjophthalmol-2012-302675. Epub 2013 May 17.
PubMed 23686001
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Evaluation of the Macula in Patients With Proliferative Diabetic Retinopathy Treated With Panretinal Photocoagulation and Bevacizumab (Avastin ®)
- ClinicalTrials.gov ID
- NCT01389505
- Acronym / sponsor ID
- CONEP16249
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic Retinopathy, Bevacizumab, Panretinal Photocoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Instituto do CoracaoOther government
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- Feb 2011
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 8 Jul 2011 (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.
This is a prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative Diabetic Retinopathy submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The patients with proliferative Diabetic Retinopathy (DR) with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity and contrast sensitivity, perform slit lamp examination, fundus examination and optic coherence tomography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according Early Treatment Diabetic Retinopathy Study that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks. This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one, three and six months after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients.
Detailed description
The current gold standard for the treatment of proliferative diabetic retinopathy is panretinal photocoagulation. Therefore this study is designed using both treatments in the same patient: intravitreal Bevacizumab plus panretinal photocoagulation in one eye, compared to panretinal photocoagulation alone in the contralateral eye. These patients had their visual acuity and contrast vision measured and complete ophthalmological examination was performed, including macular slit lamp examination, fluorescein angiography and optical coherence tomography.
Patients with similar proliferative diabetic retinopathy without high risk characteristics receive laser therapy in both eyes and intravitreal Bevacizumab injections in one eye. For the Bevacizumab injections, numbing drops, antibiotic drops, and drops to dilate the pupil, and possibly and anesthetic injection, are put in the eye before the medicine is injected into the vitreous. Patients return for follow-up visits 1 day, 1 and 4 weeks after the injection, and then 3 and 6 months. Patients whose condition does not improve may undergo new evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panretinal photocoagulation | Active comparator | Procedure: Panretinal photocoagulationGroup 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3. |
| Bevacizumab + Panretinal Photocoagulation (PRP) | Experimental | Procedure: Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of BevacizumabGroup 2: Bevacizumab intravitreous injections plus PRP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Proliferative diabetic retinopathy eyes.
- Best Corrected-Visual Acuity at baseline > 20/320 in the study eye.
- Patients with and without diabetic macular edema
- Type II diabetic subjects as defined by the World Health Organization
- aged ≥ 18 years.
Key exclusion criteria (8 listed)
- Vitreous hemorrhage or pre-retinal hemorrhage
- Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
- Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
- Cataract
- Any intraocular surgery within 6 months before trial enrollment.
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 |
|---|---|---|
| Panretinal photocoagulationThree episodes of panretinal photocoagulation with one week of interval | Procedure or surgery | Panretinal photocoagulation |
| Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of BevacizumabIntravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP | Procedure or surgery | Bevacizumab + Panretinal Photocoagulation (PRP) |
Primary outcome
Functional Macular Evaluation
Time frame: 24 weeks
During this 24 weeks of follow-up the Visual acuity (ETDRS), Contrast vision will be measured at baseline, 4, 12 and finally at 24 week
1 secondary outcome
Structural Macular Evaluation
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2011.
- Derived from this study: PubMed 28273240Preti RC, Mutti A, Ferraz DA, Zacharias LC, Nakashima Y, Takahashi WY, Monteiro ML. The effect of laser pan-retinal photocoagulation with or without intravitreal bevacizumab injections on the OCT-measured macular choroidal thickness of eyes with proliferative diabetic retinopathy. Clinics (Sao Paulo). 2017 Feb 1;72(2):81-86. doi: 10.6061/clinics/2017(02)03.
- Derived from this study: PubMed 23686001Preti RC, Ramirez LM, Monteiro ML, Carra MK, Pelayes DE, Takahashi WY. Contrast sensitivity evaluation in high risk proliferative diabetic retinopathy treated with panretinal photocoagulation associated or not with intravitreal bevacizumab injections: a randomised clinical trial. Br J Ophthalmol. 2013 Jul;97(7):885-9. doi: 10.1136/bjophthalmol-2012-302675. Epub 2013 May 17.
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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.
University Sao Paulo contact
Walter Y Takahashi, PhD principal investigator
University of Sao Paulo
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 Panretinal photocoagulation and Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab in people with Proliferative Diabetic Retinopathy, run by Instituto do Coracao 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 8 Jul 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rony C Preti, MD (+551199991636, rypreti@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Macular Evaluation (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389505, which also lists 2 linked publications.
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 8 Jul 2011.