EfficacyNCT06271473
Effect of PPV+ILM Peeling +/- Subretinal Injection of Ringer Lactate in Management of Nontractional Refractory DME
A study testing vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. in people with Efficacy and Safety, run by Ain Shams University at 2 sites in Egypt.
Trial summary
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesEgypt
- Study dates
- 30 Aug 2023to 30 Jun 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: above 40 years old.
- Patients with type two diabetes mellitus of more than 5 years duration.
- Patients with Best corrected visual acuity better than 3/60.
- Central macular thickness (CMT) of more than 250 μm despite undergoing six monthly injection of anti-VEGF therapy or corticosteroid or less than 10% reduction in CMT at the last follow up visit.
- No evidence of vitreomacular traction.
- Lens status: Pseudophakia or clear crystalline lens.
Who cannot join
- Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).
- Ischemic maculopathy by FFA.
- Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
- Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
- Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
- Presence of diabetic optic atrophy or neuropathy.
Show all 11Show fewer
- Presence of neovascular glaucoma.
- Cataractous lens either preoperatively or as intra or postoperative complication.
- Vitrectomized Eyes.
- A prior intraocular surgery within the past six-months.
- Lost follow up
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 1 recruiting
- Active, not recruiting
Ain Shams university
Cairo
- Recruiting
Ain Shams university
Cairo
Azza MA Said, MD, +201006228992, dr_azza_22@hotmail.com
David G Samuel, Msc, +201064442469, david.samuel.ophth@gmail.com
About this study
Official title: Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Read the detailed description
In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
- Being tested
- vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
- Keywords
- refractory diabetic macular edema, internal limiting membrane peeling, pars plana vitrectomy, subretinal injection of ringer lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.Procedure or surgery
vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.
| Study group | Role | What they receive |
|---|---|---|
| subjecting to vitrectomy + ILM peeling only | Active comparator | Not described Receives: Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. |
| subjecting to vitrectomy + ILM peeling + planned foveal detachment | Active comparator | Not described Receives: Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in CMT by OCT at final visit
decrease or increase in central macular thickness by OCT
Measured: after 1 month and 3 months
Secondary outcomes (1)
change in BCVA at final visit
decrease or increase in best corrected visual acuity
Measured: after 1 month and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start30 Aug 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EfficacyStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 20 eyes of 20 patients will be divided randomly into 2 groups: * Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only * Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdelrahman G Salman, MD, Principal investigator, professor at Ain Shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271473
- Sponsor's protocol ID
- AinShamsU3
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Pars Plana Vitrectomy With Internal Limiting Membrane Peeling With or Without Planned Foveal Detachment for Management of Non-tractional Refractory Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06271473
- Acronym / sponsor ID
- AinShamsU3
- Keywords
- refractory diabetic macular edema, internal limiting membrane peeling, pars plana vitrectomy, subretinal injection of ringer lactate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Feb 2024 (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.
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Detailed description
In non-tractional cases, PPV allows a more efficient clearance of VEGF and other cytokines from the retina and improves retinal oxygenation by promotion of intraocular fluid currents, and relief of any subclinical tractional forces, thereby reducing DME.
To evaluate the efficacy and safety of combined pars plana vitrectomy and planned foveal detachment through subretinal injection of ringer's solution in patients with non-tractional refractory diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 20 eyes of 20 patients will be divided randomly into 2 groups: * Group (A): 10 eyes subjecting to vitrectomy + ILM peeling only * Group (B): 10 eyes subjecting to vitrectomy + ILM peeling + planned foveal detachment via subretinal injection of ringer's solution.
| Arm | Type | Receives |
|---|---|---|
| subjecting to vitrectomy + ILM peeling only | Active comparator | Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. |
| subjecting to vitrectomy + ILM peeling + planned foveal detachment | Active comparator | Procedure: vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: above 40 years old.
Key exclusion criteria (11 listed)
- Other causes of macular edema (intraocular inflammation, retinal vein occlusion, Irvin-gass syndrome, pharmacological).
- Ischemic maculopathy by FFA.
- Presence of bad prognostic signs in OCT such as disorganization of inner retinal layers (DRIL) and extensive disruption of IS-OS junction subfoveally.
- Presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula.
- Presence of proliferative diabetic fibrovascular membranes threatening or at the macula.
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 |
|---|---|---|
| vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution.vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. | Procedure or surgery | subjecting to vitrectomy + ILM peeling + planned foveal detachment, subjecting to vitrectomy + ILM peeling only |
Primary outcome
change in CMT by OCT at final visit
Time frame: after 1 month and 3 months
decrease or increase in central macular thickness by OCT
1 secondary outcome
change in BCVA at final visit
Time frame: after 1 month and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
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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.
Abdelrahman G Salman, MD principal investigator
professor at Ain Shams university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vitrectomy + ILM peeling +/- planned foveal detachment via subretinal injection of ringer's solution. in people with Efficacy and Safety, run by Ain Shams University at 2 sites in Egypt.
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 6 inclusion and 11 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 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
Contact Azza MA Said, MD (2001006228992, dr_azza_22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in CMT by OCT at final visit (time frame: after 1 month and 3 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 6 Aug 2024.