Diabetic Retinopathy Visually ThreateningNCT04380064
Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy
A study testing ILM Peeling and No ILM Peeling in people with Diabetic Retinopathy Visually Threatening, run by Rush Eye Associates at 1 site in Mexico.
Trial summary
Subject/Participant Groups: Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Retinopathy Visually Threatening
- What is being tested?
- ILM Peeling and No ILM Peeling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2020to 1 Feb 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject age is 18-85 years.
- Subject consents to study participation and is capable of 6 months of follow-up.
- The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
- The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).
Who cannot join
- Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
- Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
- Subject has uncontrolled hypertension (systolic > 200 mmHg or diastolic > 120 mmHg) despite adherence to a multiple anti-hypertensive medication regimen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial
Subject/Participant Groups:
Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
Read the detailed description
Hypothesis:
Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.
Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.
- Being tested
- ILM Peeling, No ILM Peeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILM PeelingProcedure or surgery
ILM peeling performed during primary PPV for PDR
No ILM PeelingProcedure or surgery
ILM peeling not performed during primary PPV for PDR
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Receives: Procedure: ILM Peeling |
| Control Group | Active comparator | Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment Receives: Procedure: No ILM Peeling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ERM Development
Postoperative Epiretinal Membrane Development
Measured: 6 months
Secondary outcomes (1)
Visual Acuity
Rate of subjects achieving 20/50 or better Snellen 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 posted8 May 2020
- Study start1 May 2020
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy Visually ThreateningStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
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, MD, Study chair, panhandle eye group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04380064
- Sponsor's protocol ID
- Retina 4
- Status last verified
- Nov 2023
- First submitted
- 5 May 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy Patients Undergoing Vitrectomy for Tractional Retinal Detachment: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04380064
- Acronym / sponsor ID
- Retina 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rush Eye AssociatesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 8 May 2020 (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.
Subject/Participant Groups:
Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment
Detailed description
Hypothesis:
Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.
Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: ILM PeelingSubjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment |
| Control Group | Active comparator | Procedure: No ILM PeelingSubjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject age is 18-85 years.
- Subject consents to study participation and is capable of 6 months of follow-up.
- The subject has type I or II Diabetes Mellitus with active PDR in the study eye.
- Best-corrected spectacle visual acuity (BCSVA) on the Snellen eye chart ranges from 20/40 to hand motions in the study eye.
- The subject is determined to need a PPV for the indication of TRD (Grades 2 and 3).
Key exclusion criteria (6 listed)
- Subject is known to have a significant retinal/optic nerve disease otherwise unrelated to Diabetes Mellitus, which in the opinion of the examiner is responsible for two or more lines of reduced BCSVA (macular degeneration, optic neuritis, glaucoma, amblyopia, etc.) in the study eye.
- Subject is known to have macular ischemia, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA in the study eye.
- Subject has a significant corneal or cataract opacity, which in the opinion of the examiner, is responsible for two or more lines of reduced BCSVA (corneal scar, ectasia, etc.) in the study eye.
- Subject has had a previous vitrectomy (anterior or PPV) in the study eye.
- Subject has uncontrolled neovascular glaucoma (intraocular pressure > 30 mmHg despite medical/surgical treatment) in the study eye.
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 |
|---|---|---|
| ILM PeelingILM peeling performed during primary PPV for PDR | Procedure or surgery | Study Group |
| No ILM PeelingILM peeling not performed during primary PPV for PDR | Procedure or surgery | Control Group |
Primary outcome
Postoperative ERM Development
Time frame: 6 months
Postoperative Epiretinal Membrane Development
1 secondary outcome
Visual Acuity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Diabetic Retinopathy Visually Threatening
Recruiting
Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Proliferative Diabetic Retinopathy, 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.
Sloan Rush, MD 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 study testing ILM Peeling and No ILM Peeling in people with Diabetic Retinopathy Visually Threatening, 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 5 inclusion and 6 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 18 Nov 2023. 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.
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?
Postoperative ERM Development (time frame: 6 months). 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 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.