Diabetic Macular EdemaNCT07826286
Changes in Intraocular Pressure After Intravitreal Injection
An observational study of Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration, run by Assiut University.
Trial summary
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections introduce additional fluid volume into the eye, which can cause an acute, transient elevation in intraocular pressure (IOP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration, Retinal Vein Occlusion
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Observational
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 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients attending the Ophthalmology Department at El Mabara Hospital in Assiut, Egypt, who are scheduled to receive routine intravitreal anti-VEGF injections for vitreoretinal conditions such as diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion.
Who may be able to join
- Age 18 years or older.
- Scheduled to receive an intravitreal anti-vascular endothelial growth factor (anti-VEGF) injection for an established clinical indication (e.g., diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion).
- Provision of written informed consent prior to enrollment.
Who cannot join
- Known history of glaucoma or ocular hypertension.
- History of previous glaucoma surgery.
- Corneal diseases or ocular conditions that significantly interfere with accurate intraocular pressure measurement.
- Inability to cooperate adequately during intraocular pressure measurement.
- Refusal to participate or failure to provide informed consent.
- Development of marked intraocular pressure elevation immediately after injection (IOP ≥ 40 mmHg) requiring anterior chamber paracentesis.
About this study
Official title: Monitoring Changes in Intraocular Pressure After Intravitreal Injection
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections introduce additional fluid volume into the eye, which can cause an acute, transient elevation in intraocular pressure (IOP). The purpose of this prospective observational study is to evaluate the immediate and early changes in intraocular pressure following intravitreal anti-VEGF injections and to determine how rapidly pressure recovers toward baseline levels.
Adult participants scheduled to receive routine intravitreal anti-VEGF therapy for established clinical indications, such as diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion, will be enrolled. Intraocular pressure will be measured using an Icare rebound tonometer with single-use disposable probes before injection (baseline) and at 1 minute, 5 minutes, and 20 minutes post-injection. The study will also analyze whether factors such as refractive error, the number of prior injections, or the type of anti-VEGF drug administered affect the severity of post-injection pressure spikes and subsequent recovery.
- Conditions
- Diabetic Macular Edema, Neovascular Age-Related Macular Degeneration, Retinal Vein Occlusion, Ocular Hypertension
- Keywords
- Intraocular Pressure, Intravitreal Injections, Anti-VEGF, Icare Tonometry, Rebound Tonometry, Bevacizumab, Ranibizumab
- Medical subject headings
- Retinal Vein Occlusion, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal Anti-VEGF Injection Cohort | Patients aged 18 years and older scheduled to receive an intravitreal anti-VEGF injection for established clinical indications, including diabetic macular edema, neovascular age-related macular degeneration, or retinal vein occlusion. Participants undergo baseline ophthalmic evaluation followed by intraocular pressure (IOP) monitoring at 1 minute, 5 minutes, and 20 minutes post-injection using an Icare rebound tonometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intraocular Pressure at 1 Minute
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer with a single-use disposable probe to assess the acute post-injection pressure spike compared to baseline.
Measured: Baseline and 1 minute post-injection
Change from Baseline in Intraocular Pressure at 5 Minutes
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer with a single-use disposable probe to evaluate early post-injection pressure trends.
Measured: Baseline and 5 minutes post-injection
Change from Baseline in Intraocular Pressure at 20 Minutes
Intraocular pressure will be measured in mmHg using an Icare rebound tonometer to assess the rate and extent of pressure recovery toward pre-injection baseline levels.
Measured: Baseline and 20 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
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 Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Hussein Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826286
- Sponsor's protocol ID
- Post-Intravitreal IOP Changes
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No