NCT05861466CompletedPhase 4
Comparative Study Between IVI of Ranibizumab with and Without Prior ACP in Patients with DME Using OCT-A
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]
Source: ClinicalTrials.gov · Last updated 26 Nov 2024
Brief summary (registry, in English)
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 . \]
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 102 (actual)
- First submitted
- 2 May 2023
- Start date
- 1 Jan 2023
- Primary completion date
- 24 Nov 2024
- Lead sponsor
- Ain Shams University
- Diseases
- Diabetic eye disease
- NCT number
- NCT05861466
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 102
- From 1 Jan 2023 to the primary completion date, 24 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Usage of systemic or topical corticosteroids.
Other illness
- History of glaucoma.
- Patients with a history of intraocular surgery other than cataract surgery.
- Systemc diseases rather than hypertension and diabetes mellitus.
Lab values
- Poorly controlled diabetics (HbA1C greater than 9.0%)
Age
- Age under 40 years.
Other
- Proliferative diabetic retinopathy.
- OCT-Angiographic evidence of ischemia (enlarged foveal avascular zone, paramacular areas of capillary nonperfusion)
- Neovascular AMD in the study eye.
- Tilted disc and optic disc anomalies.
- One-eyed patients.
- Corneal opacities that might hinder acquisition of good quality OCT images.
Who the study is looking for
- 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.
Age in the registry: 40 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ain Shams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.