Diabetic RetinopathyPhase 1/2NCT01746563
Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Proliferative Diabetic Retinopathy
A Phase 1/2 study testing Ranibizumab and Laser therapy in people with Diabetic Retinopathy and Retinal Diseases, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Retinal Diseases, Eye Diseases
- What is being tested?
- Ranibizumab and Laser therapy
- 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
- May 2011to Aug 2012
- Phase
- Phase 1/2
- 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
- Naive 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.
About this study
Official title: Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy
To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).
Read the detailed description
Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).
Objectives:
Primary objective:
The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).
Secondary objectives:
To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.
To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.
Strategic goal:
The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome
- Conditions
- Diabetic Retinopathy, Retinal Diseases, Eye Diseases, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases
- Being tested
- Ranibizumab, Laser therapy
- Keywords
- Proliferative Diabetic Retinopathy, Ranibizumab, Panretinal Photocoagulation
- Medical subject headings
- Diabetic Retinopathy, Retinal Diseases, Eye Diseases, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis (Novartis)
Intravitreal injection
Laser therapyProcedure or surgery
Laser therapy
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Ranibizumab 0,05 mg intravitreal injection Receives: Drug: Ranibizumab; Procedure: Laser therapy |
| Laser Therapy | Active comparator | Laser Therapy alone Receives: Procedure: Laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular Evaluation
Changes between visual acuity from baseline to month 6.
Measured: 6 Months
Secondary outcomes (1)
Structural Macular Evaluation
Change on retinal thickness between baseline and Month 6
Measured: 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2012
- Study completionAug 2012
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 Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Araujo Ferraz, University of Sao Paulo
- Investigators
- Walter Y Takahashi, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746563
- Sponsor's protocol ID
- USP-RBZ2012
- Status last verified
- Dec 2012
- First submitted
- 6 Dec 2012
- Last updated
- 11 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rentiya ZS, Ferraz DA, Hutnik R, Bae J, Machado CG, Mucciolli C, Motta AALD, Ribeiro LZ, Guan Z, Preti RC, Takahashi WY. Evaluation of contrast sensitivity in non-high-risk proliferative diabetic retinopathy treated with panretinal photocoagulation with and without intravitreal injections of ranibizumab. Arq Bras Oftalmol. 2022 Jan-Feb;85(1):37-45. doi: 10.5935/0004-2749.20220006.
PubMed 34586227Ferraz DA, Vasquez LM, Preti RC, Motta A, Sophie R, Bittencourt MG, Sepah YJ, Monteiro ML, Nguyen QD, Takahashi WY. A randomized controlled trial of panretinal photocoagulation with and without intravitreal ranibizumab in treatment-naive eyes with non-high-risk proliferative diabetic retinopathy. Retina. 2015 Feb;35(2):280-7. doi: 10.1097/IAE.0000000000000363.
PubMed 25272318
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Ranibizumab Combined With Panretinal Photocoagulation in Patients With Treatment-Naive Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01746563
- Acronym / sponsor ID
- USP-RBZ2012
- Conditions
- Diabetic Retinopathy, Retinal Diseases, Eye Diseases, Diabetic Angiopathies, Vascular Diseases, Cardiovascular Diseases
- Keywords
- Proliferative Diabetic Retinopathy, Ranibizumab, Panretinal Photocoagulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Dec 2012 (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.
To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).
Detailed description
Comparative efficacy of combined treatment including intravitreal injection of 0.5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with Proliferative Diabetic Retinopathy (PDR).
Objectives:
Primary objective:
The primary objective will be to evaluate the efficacy of combined treatment with ranibizumab and laser photocoagulation versus laser photocoagulation alone in patients with severe PDR by the mean change in BCVA at V7/M6 compared to baseline. The Best Visual Acuity (BCVA) measured by the Early Treatment Diabetic Retinopathy Study (EDTRS).
Secondary objectives:
To evaluate differences in Optic Coherence Tomography (OCT) retinal thickness and total macular volume of combined treatment regiment including intravitreal injection of 0,5 mg of Lucentis (ranibizumab) and laser photocoagulation for patients with PDR at visit 7 compared to the baseline assessments.
To evaluate the percentage of patients that present with vitreous hemorrhage after the beginning of the laser treatment at visit 7 compared to the baseline assessments.
Strategic goal:
The main goal of this study is to evaluate if the use of intravitreal ranibizumab in eyes submitted to Pan-Retinal Photocoagulation (PRP) due to PDR induces less macular edema and less vitreous hemorrhage and therefore leads to a better visual outcome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab, Procedure: Laser therapyRanibizumab 0,05 mg intravitreal injection |
| Laser Therapy | Active comparator | Procedure: Laser therapyLaser Therapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Naive 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
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 |
|---|---|---|
| RanibizumabAlso: Lucentis (Novartis)Intravitreal injection | Drug | Ranibizumab |
| Laser therapyLaser therapy | Procedure or surgery | Laser Therapy, Ranibizumab |
Primary outcome
Macular Evaluation
Time frame: 6 Months
Changes between visual acuity from baseline to month 6.
1 secondary outcome
Structural Macular Evaluation
Time frame: 06 months
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 11 Dec 2012.
- Derived from this study: PubMed 34586227Rentiya ZS, Ferraz DA, Hutnik R, Bae J, Machado CG, Mucciolli C, Motta AALD, Ribeiro LZ, Guan Z, Preti RC, Takahashi WY. Evaluation of contrast sensitivity in non-high-risk proliferative diabetic retinopathy treated with panretinal photocoagulation with and without intravitreal injections of ranibizumab. Arq Bras Oftalmol. 2022 Jan-Feb;85(1):37-45. doi: 10.5935/0004-2749.20220006.
- Derived from this study: PubMed 25272318Ferraz DA, Vasquez LM, Preti RC, Motta A, Sophie R, Bittencourt MG, Sepah YJ, Monteiro ML, Nguyen QD, Takahashi WY. A randomized controlled trial of panretinal photocoagulation with and without intravitreal ranibizumab in treatment-naive eyes with non-high-risk proliferative diabetic retinopathy. Retina. 2015 Feb;35(2):280-7. doi: 10.1097/IAE.0000000000000363.
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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.
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 1/2 study testing Ranibizumab and Laser therapy in people with Diabetic Retinopathy and Retinal Diseases, run by University of Sao 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 7 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: finished, as of the sponsor's last update on 11 Dec 2012. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Macular Evaluation (time frame: 6 Months). 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 NCT01746563, 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 11 Dec 2012.