Proliferative Diabetic RetinopathyNCT03609996
Retrospective Review of Proliferative Diabetic Retinopathy Patients
An observational study of Proliferative Diabetic Retinopathy, run by Elman Retina Group at 1 site in United States.
Trial summary
The primary objective of the protocol is to determine if intravitreal ranibizumab alone decreases retinal neovascularization from Proliferative Diabetic Retinopathy (PDR) with deferred panretinal photocoagulation (PRP) and/or vitrectomy at one year after treatment with ranibizumab has been initiated. 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 Lucentis
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 1 Dec 2019
- Phase
- Observational
- 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
Study population: Approximately 160 eyes that have been diagnosed with PDR that have been treated with ranibizumab will be looked at retrospectively.
Who may be able to join
- Age >= 18 years Individuals <18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
- 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 anti-hyperglycemia agents for the treatment of diabetes
- Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for definitions
- Presence of PDR which the investigator has treated the study eye(s) with ranibizumab
Who cannot join
- History of prior panretinal photocoagulation prior to initiating ranibizumab
- 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)
- History of vitrectomy prior to initiating ranibizumab
- Treatment with Ranibizumab within six months of treatment regimen
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Review of Patients With Proliferative Diabetic Retinopathy and Regression of PDR After Treatment With Ranibizumab
The primary objective of the protocol is to determine if intravitreal ranibizumab alone decreases retinal neovascularization from Proliferative Diabetic Retinopathy (PDR) with deferred panretinal photocoagulation (PRP) and/or vitrectomy at one year after treatment with ranibizumab has been initiated.
Read the detailed description
Current standard treatment for Proliferative Diabetic Retinopathy (PDR) is panretinal photocoagulation (PRP), but this treatment is inherently destructive and has several potential adverse effects on aspects of visual function, including constriction of peripheral visual fields and decreases in night vision, contrast sensitivity and color perception. Thus, therapeutic alternatives that might delay or obviate the need for PRP are desirable. It has been demonstrated that retinal neovascularization from PDR is highly responsive to anti-VEGF therapy, but it is unclear how long regression of retinal neovascularization is sustained after anti- VEGF therapy is halted in clinical practice.
It is possible that intravitreal ranibizumab treatment could prevent laser-associated vision loss by precluding the need for PRP as long as the eye continued to receive ranibizumab. Even if ranibizumab treatment was discontinued, it is possible that initial treatment with anti-VEGF therapy might improve visual outcomes substantially by delaying or preventing the need for PRP, and the infrequent frequency of administration of ranibizumab for DME (median 2 to 3 times in the second year of treatment) after the DME initially has resolved on anti-VEGF therapy suggests that monthly ranibizumab might not be needed to achieve control of PDR.
The Diabetic Retinopathy Clinical Research Network (DRCR network) is currently evaluating intravitreal ranibizumab treatment to see if can prevent laser-associated vision loss by precluding the need for PRP as long as the eye continued to receive ranibizumab. However, intravitreal injections carry the risk of serious complications. Ophthalmic complications include endophthalmitis in 2% of all injected patients cumulatively. Endophthalmitis is a vision threatening and can cause severe and permanent vision loss and even loss of the eye. Other complications include vitreous hemorrhage, retinal detachment, uveitis and glaucoma. This study will evaluate ranibizumab usage as the primary treatment for PDR in a busy private clinical practice.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Panretinal Photocoagulation, Lucentis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal PhotocoagulationDevice
Laser treatment for PDR
LucentisDrug
Intraviteral injection
| Study group | Role | What they receive |
|---|---|---|
| PDR treated with Laser | Not described Receives: Device: Panretinal Photocoagulation; Drug: Lucentis | |
| PDR treated with Lucentis | Not described Receives: Device: Panretinal Photocoagulation; Drug: Lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical regression of neovascularization not requiring further treatment beyond RBZ
Clinical regression of neovascularization not requiring further treatment beyond RBZ
Measured: 2009-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Jun 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elman Retina Group
- Sponsor type
- University, hospital or other
- Collaborators
- Roche-Genentech
- Responsible party
- Sponsor
- Investigators
- Michael Elman, Principal investigator, Elman Retina Group, P.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609996
- Sponsor's protocol ID
- ML29652
- Status last verified
- Feb 2019
- First submitted
- 24 Jul 2018
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Review of Patients With Proliferative Diabetic Retinopathy and Regression of PDR After Treatment With Ranibizumab
- ClinicalTrials.gov ID
- NCT03609996
- Acronym / sponsor ID
- ML29652
- Conditions
- Proliferative Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Elman Retina GroupUniversity, hospital or other
- Collaborators
- Roche-Genentech
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 1 Aug 2018 (actual)
- 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 primary objective of the protocol is to determine if intravitreal ranibizumab alone decreases retinal neovascularization from Proliferative Diabetic Retinopathy (PDR) with deferred panretinal photocoagulation (PRP) and/or vitrectomy at one year after treatment with ranibizumab has been initiated.
Detailed description
Current standard treatment for Proliferative Diabetic Retinopathy (PDR) is panretinal photocoagulation (PRP), but this treatment is inherently destructive and has several potential adverse effects on aspects of visual function, including constriction of peripheral visual fields and decreases in night vision, contrast sensitivity and color perception. Thus, therapeutic alternatives that might delay or obviate the need for PRP are desirable. It has been demonstrated that retinal neovascularization from PDR is highly responsive to anti-VEGF therapy, but it is unclear how long regression of retinal neovascularization is sustained after anti- VEGF therapy is halted in clinical practice.
It is possible that intravitreal ranibizumab treatment could prevent laser-associated vision loss by precluding the need for PRP as long as the eye continued to receive ranibizumab. Even if ranibizumab treatment was discontinued, it is possible that initial treatment with anti-VEGF therapy might improve visual outcomes substantially by delaying or preventing the need for PRP, and the infrequent frequency of administration of ranibizumab for DME (median 2 to 3 times in the second year of treatment) after the DME initially has resolved on anti-VEGF therapy suggests that monthly ranibizumab might not be needed to achieve control of PDR.
The Diabetic Retinopathy Clinical Research Network (DRCR network) is currently evaluating intravitreal ranibizumab treatment to see if can prevent laser-associated vision loss by precluding the need for PRP as long as the eye continued to receive ranibizumab. However, intravitreal injections carry the risk of serious complications. Ophthalmic complications include endophthalmitis in 2% of all injected patients cumulatively. Endophthalmitis is a vision threatening and can cause severe and permanent vision loss and even loss of the eye. Other complications include vitreous hemorrhage, retinal detachment, uveitis and glaucoma. This study will evaluate ranibizumab usage as the primary treatment for PDR in a busy private clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDR treated with Laser | – | Device: Panretinal Photocoagulation, Drug: Lucentis |
| PDR treated with Lucentis | – | Device: Panretinal Photocoagulation, Drug: Lucentis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 160 eyes that have been diagnosed with PDR that have been treated with ranibizumab will be looked at retrospectively.
Key inclusion criteria (7 listed)
- Age >= 18 years Individuals <18 years old are not being included because PDR is so rare in this age group that the diagnosis of PDR may be questionable.
- 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:
- Presence of PDR which the investigator has treated the study eye(s) with ranibizumab
Key exclusion criteria (5 listed)
- History of prior panretinal photocoagulation prior to initiating ranibizumab
- Tractional retinal detachment involving the macula.
- History of vitrectomy prior to initiating ranibizumab
- Treatment with Ranibizumab within six months of treatment regimen
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 PhotocoagulationLaser treatment for PDR | Device | PDR treated with Laser, PDR treated with Lucentis |
| LucentisIntraviteral injection | Drug | PDR treated with Laser, PDR treated with Lucentis |
Primary outcome
Clinical regression of neovascularization not requiring further treatment beyond RBZ
Time frame: 2009-2018
Clinical regression of neovascularization not requiring further treatment beyond RBZ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
Related trials for Proliferative Diabetic Retinopathy
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy
Diabetic Retinopathy
RecruitingObservational study
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Diabetic Retinopathy, Diabetes Mellitus, Type 2
Not yet recruitingPhase 4
Continuous Delivery of Ranibizumab Via the Port Delivery System for Proliferative Diabetic Retinopathy-related Vitreous Hemorrhage With Pars Plana Vitrectomy and Limited PRP.
Proliferative Diabetic Retinopathy, Diabetic Retinopathy
Active, not recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of Orally Administered VX-01
Diabetic Retinopathy, NPDR - Non Proliferative Diabetic Retinopathy
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.
Michael Elman principal investigator
Elman Retina Group, P.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proliferative Diabetic Retinopathy, run by Elman Retina Group at 1 site in United States.
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 5 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 7 Feb 2019. 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 United States. 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.
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?
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?
Clinical regression of neovascularization not requiring further treatment beyond RBZ (time frame: 2009-2018). 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 7 Feb 2019.