Diabetic Macular EdemaPhase 4NCT05861466
Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A
A Phase 4 study testing intra-vitreal injection of Ranibizumab and anterior chamber paracentesis in people with Diabetic Macular Edema, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present . Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- intra-vitreal injection of Ranibizumab and anterior chamber paracentesis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 24 Nov 2024
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with diabetes mellitus type II.
- Patients with visual acuity > 0.1, able to fixate and with clear visual media.
- Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.
Who cannot join
- Age under 40 years.
- Poorly controlled diabetics (HbA1C greater than 9.0%)
- Proliferative diabetic retinopathy.
- OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
- Neovascular AMD in the study eye.
- History of glaucoma.
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- Tilted disc and optic disc anomalies.
- One-eyed patients.
- Usage of systemic or topical corticosteroids.
- Patients with a history of intraocular surgery other than cataract surgery.
- Systemc diseases rather than hypertension and diabetes mellitus.
- Corneal opacities that might hinder acquisition of good quality OCT images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]
The goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .
The main question[s]it aims to answer are:
•[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?] •[is there any effect of Prior Anterior Chamber Paracentesis?] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . ]
- Conditions
- Diabetic Macular Edema
- Being tested
- intra-vitreal injection of Ranibizumab, anterior chamber paracentesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra-vitreal injection of RanibizumabDrug
The intravitreal injection will be performed with ranibizumab (0.5 mg/0.05 mL through a 27-gauge needle that will be inserted into the sclera 3.5 mm from the corneal limbus in pseudophakic patients, and 4 mm in phakic patients.
anterior chamber paracentesisProcedure or surgery
A 27-gauge needle on a 1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis. Receives: Drug: intra-vitreal injection of Ranibizumab |
| Group B | Active comparator | Patients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis. Receives: Drug: intra-vitreal injection of Ranibizumab; Procedure: anterior chamber paracentesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the acute change in angiographic parameters
OCTA of macula and peripapillary region with documentation of vessel density
Measured: 1 day
Secondary outcomes (1)
the acute change in intra-ocular pressure
Goldman applanation tonometry for evaluation of IOP
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start1 Jan 2023
- Primary completion24 Nov 2024
- Study completion24 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Sanad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861466
- Sponsor's protocol ID
- MD 1692022
- Status last verified
- Nov 2024
- First submitted
- 2 May 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intravitreal Injection of Ranibizumab with and Without Prior Anterior Chamber Paracentesis in Patients with Diabetic Macular Oedema Using Optical Coherence Tomography Angiography [OCT-A]
- ClinicalTrials.gov ID
- NCT05861466
- Acronym / sponsor ID
- MD 1692022
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 24 Nov 2024 (actual)
- First posted
- 16 May 2023 (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 goal of this clinical trial is to to evaluate the changes in retinal microvasculature secondary to intra-ocular pressure changes post intra-vitreal injection in patients with diabetic macular oedema highlighting the effect of prior anterior chamber paracentesis on such changes if present .
The main question[s]it aims to answer are:
•[is there any effect of post intra-vitreal injection IOP spikes on retinal microvasculature?] •[is there any effect of Prior Anterior Chamber Paracentesis?] Participants in group A will be subjected to an identified approved treatment( intra-vitreal injection)\& Participants in group B will be subjected to a prior ACP with the intra-vitreal injection . ]
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: intra-vitreal injection of RanibizumabPatients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab without Anterior Chamber Paracentesis. |
| Group B | Active comparator | Drug: intra-vitreal injection of Ranibizumab, Procedure: anterior chamber paracentesisPatients with eyes with non ischemic diffuse center involving DME will be assigned to receive IVI of ranibizumab with Anterior Chamber Paracentesis. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with diabetes mellitus type II.
- Patients with visual acuity > 0.1, able to fixate and with clear visual media.
- Patients with eyes with non ischemic diffuse center involving DME were randomly assigned to receive IVI of ranibizumab either without (group A) or with (group B) ACP.
Key exclusion criteria (12 listed)
- Age under 40 years.
- Poorly controlled diabetics (HbA1C greater than 9.0%)
- Proliferative diabetic retinopathy.
- OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
- Neovascular AMD 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 |
|---|---|---|
| intra-vitreal injection of RanibizumabThe intravitreal injection will be performed with ranibizumab (0.5 mg/0.05 mL through a 27-gauge needle that will be inserted into the sclera 3.5 mm from the corneal limbus in pseudophakic patients, and 4 mm in phakic patients. | Drug | Group A, Group B |
| anterior chamber paracentesisA 27-gauge needle on a 1-mL syringe will be inserted into the anterior chamber of the eye, and approximately 0.05 mL of aqueous humor will be withdrawn. | Procedure or surgery | Group B |
Primary outcome
the acute change in angiographic parameters
Time frame: 1 day
OCTA of macula and peripapillary region with documentation of vessel density
1 secondary outcome
the acute change in intra-ocular pressure
Time frame: 1 day
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 26 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intra-vitreal injection of Ranibizumab and anterior chamber paracentesis in people with Diabetic Macular Edema, run by Ain Shams University at 1 site 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 3 inclusion and 12 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 26 Nov 2024. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the acute change in angiographic parameters (time frame: 1 day). 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 26 Nov 2024.