Proliferative Diabetic RetinopathyPhase 2/3NCT02705274
PRP vs Bevacizumab for PDR Treatment
A Phase 2/3 study testing Bevacizumab and Panretinal photocoagulation in people with Proliferative Diabetic Retinopathy, run by Marashi Eye Clinic at 1 site in Syria.
Trial summary
Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy, however with some visual functional benefits and less complications with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Bevacizumab and Panretinal photocoagulation
- 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 siteSyria
- Study dates
- Feb 2016to May 2017
- Phase
- Phase 2/3
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal Bevacizumab , in the investigator's judgment.
- Best corrected Snellen equivalent 20/320 or higher on the day of randomization.
- Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT.
Who cannot join
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Tractional retinal detachment involving the macula. -- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal Bevacizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal Bevacizumab
- Macular edema is present that is considered to be related to ocular surgery such as cataract extraction orclinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of any macular edema.
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- An ocular condition is present (other than diabetic retinopathy) that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein or artery occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma,
- Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye were otherwise normal).
- History of intravitreal anti-VEGF treatment at any time in the past 2 months.
- History of corticosteroid treatment (intravitreal ) at any time in the past 4 months.
- History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
- Uncontrolled glaucoma (in investigator's judgment).
- Aphakia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy, however with some visual functional benefits and less complications with Ranibizumab arm.
Applying Protocol S in real world scenario may add cost burden to the patient as patients need about 7 injections per year which will cost the patient about 7000 US dollars a year as minimum The primary objective of this protocol is to determine the visual acuity outcomes at 1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg instead of Ranbizumab to lower the cost burden
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Bevacizumab, Panretinal photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met.
Panretinal photocoagulationProcedure or surgery
Panretinal photocoagulation (full session completed within 42 days).
| Study group | Role | What they receive |
|---|---|---|
| Prompt Panretinal Photocoagulation | Active comparator | PRP= Panretinal Photocoagulation. PRP alone. Receives: Procedure: Panretinal photocoagulation |
| Bevacizumab with deferred PRP | Experimental | Bevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated. Receives: Drug: Bevacizumab; Procedure: Panretinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year
Measured: 1 year
Secondary outcomes (5)
Amount of treatment cost
Measured: 1 year
Percent of eyes with vitreous hemorrhage
Measured: 1 year
Proportion of eyes with complete regression of neovascularization on fundus photograph
Measured: 1 year
Proportion of eyes with progression to central subfield involved diabetic macular edema
Measured: 1 year
Proportion of eyes Need for Vitrectomy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marashi Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ameen Marashi, Marashi Eye Clinic
- Investigators
- Ameen Marashi, MD, Principal investigator, Marashi Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02705274
- Sponsor's protocol ID
- Protocol PDR 1
- Status last verified
- Jul 2017
- First submitted
- 29 Feb 2016
- Last updated
- 6 Jul 2017
- Results posted
- No
Publications
Marashi A, Abukhalaf I, Alfaraji R, Choman Y, Salahieh A (2017) Panretinal Photocoagulation versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy Treatment. Adv Ophthalmol Vis Syst 7(1): 00211. DOI: 10.15406/aovs.2017.07.00211
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panretinal Photocoagulation Versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT02705274
- Acronym / sponsor ID
- Protocol PDR 1
- Conditions
- Proliferative Diabetic Retinopathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marashi Eye ClinicUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 10 Mar 2016 (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.
Protocol S by DRCR.net has shown that receive Ranibizumab as anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy, however with some visual functional benefits and less complications with Ranibizumab arm.
Applying Protocol S in real world scenario may add cost burden to the patient as patients need about 7 injections per year which will cost the patient about 7000 US dollars a year as minimum The primary objective of this protocol is to determine the visual acuity outcomes at 1 year in eyes with proliferative diabetic retinopathy (PDR) using Bevacizumab 1.25 mg instead of Ranbizumab to lower the cost burden
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prompt Panretinal Photocoagulation | Active comparator | Procedure: Panretinal photocoagulationPRP= Panretinal Photocoagulation. PRP alone. |
| Bevacizumab with deferred PRP | Experimental | Drug: Bevacizumab, Procedure: Panretinal photocoagulationBevacizumab = Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >= 18 years
- Diagnosis of diabetes mellitus (type 1 or type 2)
- Presence of PDR which the investigator intends to manage with PRP alone but for which PRP can be deferred for at least 4 weeks in the setting of intravitreal Bevacizumab , in the investigator's judgment.
- Best corrected Snellen equivalent 20/320 or higher on the day of randomization.
- Media clarity, pupillary dilation, and study participant cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT.
Key exclusion criteria (14 listed)
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization.
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Tractional retinal detachment involving the macula. -- A tractional retinal detachment is not an exclusion if it is outside of the posterior pole (not threatening the macula) and in the investigator's judgment, is not a contraindication to intravitreal Bevacizumab treatment and also does not preclude deferring PRP for at least 4 weeks in the setting of intravitreal Bevacizumab
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 |
|---|---|---|
| BevacizumabDrug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria. Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met. | Drug | Bevacizumab with deferred PRP |
| Panretinal photocoagulationPanretinal photocoagulation (full session completed within 42 days). | Procedure or surgery | Bevacizumab with deferred PRP, Prompt Panretinal Photocoagulation |
Primary outcome
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year
Time frame: 1 year
5 secondary outcomes
Amount of treatment cost
Time frame: 1 year
Percent of eyes with vitreous hemorrhage
Time frame: 1 year
Proportion of eyes with complete regression of neovascularization on fundus photograph
Time frame: 1 year
Proportion of eyes with progression to central subfield involved diabetic macular edema
Time frame: 1 year
Proportion of eyes Need for Vitrectomy
Time frame: 1 year
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 6 Jul 2017.
- Results publicationMarashi A, Abukhalaf I, Alfaraji R, Choman Y, Salahieh A (2017) Panretinal Photocoagulation versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy Treatment. Adv Ophthalmol Vis Syst 7(1): 00211. DOI: 10.15406/aovs.2017.07.00211
- Marashi A, Abukhalaf I, Alfaraji R, Choman Y, Salahieh A (2017) Panretinal Photocoagulation versus Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy Treatment. Adv Ophthalmol Vis Syst 7(1): 00211. DOI: 10.15406/aovs.2017.07.00211Link provided by the sponsor.
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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.
Ameen Marashi, MD principal investigator
Marashi Eye Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bevacizumab and Panretinal photocoagulation in people with Proliferative Diabetic Retinopathy, run by Marashi Eye Clinic at 1 site in Syria.
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 5 inclusion and 14 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 6 Jul 2017. 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 Syria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of visual acuity improvement using Snellen chart or equivalent from baseline and 1 year (time frame: 1 year). 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 NCT02705274, which also lists 1 linked publication.
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 6 Jul 2017.