Diabetic RetinopathyPhase 3NCT03660345
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
A Phase 3 study testing PPV/MP and Intravitreal injection in people with Diabetic Retinopathy and Macular Edema, run by Rush Eye Associates at 1 site in Mexico.
Trial summary
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Diabetic Retinopathy, Macular Edema
- What is being tested?
- PPV/MP and Intravitreal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteMexico
- Study dates
- 4 Sep 2018to 4 May 2021
- Phase
- Phase 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient able and willing to provide informed consent
- Diagnosis of diabetes mellitus (type 1 or type 2) is established.
- Patient has non-proliferative diabetic retinopathy and is treatment-naïve for diabetic retinopathy in the study eye. (Patients may NOT have received treatment of any kind for diabetic retinopathy to the study eye).
- Best corrected visual acuity letter score is 20/32 or worse, and 20/400 or better at the time of randomization in the study eye.
- On clinical exam, definite retinal thickening due to diabetic macular edema involving the center of the macula is present in the study eye.
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- Central subfield thickness on the spectral domain OCT is greater than 300 microns at the time of randomization in the study eye.
- (The investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality).
- The study eye has no history of intraocular surgery within the previous four months. Previous uncomplicated cataract surgery otherwise shall be allowed if the study eye is longer than four months out at the time of randomization.
Who cannot join
- Proliferative diabetic retinopathy of any kind including neovascularization of the disc/retina/iris, presence of any degree of vitreous hemorrhage, and tractional retinal detachment must be excluded.
- Patients that received treatment to the posterior segment for any retinal condition must be excluded. Such treatments include intravitreal injections of any kind, retinal lasers of any kind, and subtenons injections.
- The study eye has a history of previous anterior or pars plana vitrectomy for any reason must be excluded.
- The patient has a history of systemic anti-VEGF therapy or systemic corticosteroid therapy within the previous 12 months.
- The patient's macular edema is considered to be due to a cause other than diabetic macular edema.
- An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, a nonretinal condition like corneal scarring or advanced optic nerve cupping from glaucoma, etc.).
- Substantial cataract that, in the opinion of the investigator, is likely decreasing visual acuity by three or more lines on its own merit (apart from the macular edema).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.
Read the detailed description
Diabetic retinopathy is the number one cause of vision loss in working-age adults, and macular edema is the most frequent cause of visual impairment in diabetic patients. Diabetic macular edema (DME) has been treated by a number of different modalities including focal and grid laser, intravitreal corticosteroids, intravitreal anti-vascular endothelial growth factor (VEGF) medications, and pars plana vitrectomy (PPV) with or without internal limiting membrane peeling.
PPV for the treatment of DME was first described in 1992 by Lewis et al, and since then has been studied by numerous investigators under a variety of different clinical settings including the presence of epiretinal membranes, vitreomacular traction (VMT), and diffuse DME. The postulated mechanisms by which PPV may improve DME have included a reduction in macular tangential and anterior-posterior traction, improved oxygenation of the vitreous cavity, and enhanced diffusion of vasogenic growth factors. Other factors that may modulate the response to PPV comprise the patient's lens status and the presence of macular ischemia.
PPV for DME has usually been considered only in patients that responded poorly to other interventions such as laser and/or intravitreal therapy. Typically, such patients have chronic and diffuse DME with, or without, concomitant VMT. Several small prospective, controlled trials have been performed to assess the merits of PPV as a treatment option for such recalcitrant cases with generally disappointing functional outcomes despite having structural improvements. However, since PPV was reserved as a last-ditch effort following a long ordeal with what included multiple lasers and/or intravitreal injections, it should not be surprising that visual outcomes were poor under such circumstances. Presumably most of these patients already would have had irreversible damage to the retina with little or no potential for visual acuity improvement no matter what the intervention might have been. Currently, there are no reports in the literature evaluating PPV as an initial treatment for DME. In this study, we compare PPV to anti-VEGF monotherapy in treatment-naïve subjects with DME in order to evaluate the potential role of PPV in the management of DME before irreversible retinal damage caused by long-standing and persistent DME has set in.
- Conditions
- Diabetic Retinopathy, Macular Edema
- Being tested
- PPV/MP, Intravitreal injection
- Medical subject headings
- Diabetic Retinopathy, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPV/MPProcedure or surgery
23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling
Intravitreal injectionDrug
Intravitreal ziv-Aflibercept
| Study group | Role | What they receive |
|---|---|---|
| PPV/MP | Experimental | Study Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo pars plana vitrectomy with internal limiting membrane peeling Receives: Procedure: PPV/MP |
| Intravitreal Injection | Active comparator | Control Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo intravitreal ziv-aflibercept monotherapy according to a fixed treatment schedule Receives: Drug: Intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Best-corrected visual acuity
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start4 Sep 2018
- Primary completion4 May 2021
- Study completion4 May 2021
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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush Eye Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sloan W. Rush, MD, Rush Eye Associates
- Investigators
- Sloan Rush, Study chair, panhandle eye group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660345
- Sponsor's protocol ID
- Retina 1
- Status last verified
- Nov 2021
- First submitted
- 4 Sep 2018
- Last updated
- 2 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rush RB, Rush SW. Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naive Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study. Clin Ophthalmol. 2021 Jun 21;15:2619-2624. doi: 10.2147/OPTH.S320214. eCollection 2021.
PubMed 34188440
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pars Plana Vitrectomy With Internal Limiting Membrane Peeling Versus Intravitreal Ziv-Aflibercept for Treatment-Naïve Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03660345
- Acronym / sponsor ID
- Retina 1
- Conditions
- Diabetic Retinopathy, Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Rush Eye AssociatesUniversity, hospital or other
- Study start
- 4 Sep 2018 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 6 Sep 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.
Treatment-naïve subjects with center-involved diabetic macular edema undergoing pars plana vitrectomy with internal limiting membrane peeling will have similar visual outcomes but better anatomical outcomes compared to subjects undergoing intravitreal bevacizumab monotherapy at one year.
Detailed description
Diabetic retinopathy is the number one cause of vision loss in working-age adults, and macular edema is the most frequent cause of visual impairment in diabetic patients. Diabetic macular edema (DME) has been treated by a number of different modalities including focal and grid laser, intravitreal corticosteroids, intravitreal anti-vascular endothelial growth factor (VEGF) medications, and pars plana vitrectomy (PPV) with or without internal limiting membrane peeling.
PPV for the treatment of DME was first described in 1992 by Lewis et al, and since then has been studied by numerous investigators under a variety of different clinical settings including the presence of epiretinal membranes, vitreomacular traction (VMT), and diffuse DME. The postulated mechanisms by which PPV may improve DME have included a reduction in macular tangential and anterior-posterior traction, improved oxygenation of the vitreous cavity, and enhanced diffusion of vasogenic growth factors. Other factors that may modulate the response to PPV comprise the patient's lens status and the presence of macular ischemia.
PPV for DME has usually been considered only in patients that responded poorly to other interventions such as laser and/or intravitreal therapy. Typically, such patients have chronic and diffuse DME with, or without, concomitant VMT. Several small prospective, controlled trials have been performed to assess the merits of PPV as a treatment option for such recalcitrant cases with generally disappointing functional outcomes despite having structural improvements. However, since PPV was reserved as a last-ditch effort following a long ordeal with what included multiple lasers and/or intravitreal injections, it should not be surprising that visual outcomes were poor under such circumstances. Presumably most of these patients already would have had irreversible damage to the retina with little or no potential for visual acuity improvement no matter what the intervention might have been. Currently, there are no reports in the literature evaluating PPV as an initial treatment for DME. In this study, we compare PPV to anti-VEGF monotherapy in treatment-naïve subjects with DME in order to evaluate the potential role of PPV in the management of DME before irreversible retinal damage caused by long-standing and persistent DME has set in.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPV/MP | Experimental | Procedure: PPV/MPStudy Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo pars plana vitrectomy with internal limiting membrane peeling |
| Intravitreal Injection | Active comparator | Drug: Intravitreal injectionControl Group: Treatment-naïve subjects with center-involved diabetic macular edema undergo intravitreal ziv-aflibercept monotherapy according to a fixed treatment schedule |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Patient able and willing to provide informed consent
- Diagnosis of diabetes mellitus (type 1 or type 2) is established.
- Patient has non-proliferative diabetic retinopathy and is treatment-naïve for diabetic retinopathy in the study eye. (Patients may NOT have received treatment of any kind for diabetic retinopathy to the study eye).
- Best corrected visual acuity letter score is 20/32 or worse, and 20/400 or better at the time of randomization in the study eye.
Key exclusion criteria (7 listed)
- Proliferative diabetic retinopathy of any kind including neovascularization of the disc/retina/iris, presence of any degree of vitreous hemorrhage, and tractional retinal detachment must be excluded.
- Patients that received treatment to the posterior segment for any retinal condition must be excluded. Such treatments include intravitreal injections of any kind, retinal lasers of any kind, and subtenons injections.
- The study eye has a history of previous anterior or pars plana vitrectomy for any reason must be excluded.
- The patient has a history of systemic anti-VEGF therapy or systemic corticosteroid therapy within the previous 12 months.
- The patient's macular edema is considered to be due to a cause other than diabetic macular edema.
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 |
|---|---|---|
| PPV/MP23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling | Procedure or surgery | PPV/MP |
| Intravitreal injectionIntravitreal ziv-Aflibercept | Drug | Intravitreal Injection |
Primary outcome
BCVA
Time frame: 6 months
Best-corrected visual acuity
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 2 Dec 2021.
- Derived from this study: PubMed 34188440Rush RB, Rush SW. Pars Plana Vitrectomy with Internal Limiting Membrane Peeling for Treatment-Naive Diabetic Macular Edema: A Prospective, Uncontrolled Pilot Study. Clin Ophthalmol. 2021 Jun 21;15:2619-2624. doi: 10.2147/OPTH.S320214. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Sloan Rush study chair
panhandle eye group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PPV/MP and Intravitreal injection in people with Diabetic Retinopathy and Macular Edema, run by Rush Eye Associates at 1 site 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 9 inclusion and 7 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 2 Dec 2021. 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 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. 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 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?
BCVA (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 NCT03660345, 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 2 Dec 2021.