Macular EdemaNCT05003258
Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients with Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
A study testing Intravitreal injection of Dexamethasone implant in people with Macular Edema and Retinal Vein Occlusion, run by Assiut University at 1 site in Egypt.
Trial summary
Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Intravitreal injection of Dexamethasone implant
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Oct 2021to 30 Oct 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with macular edema secondary to BRVO and CRVO.
- Presence of macular edema >3oo μ on OCT evaluation.
- visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
Who cannot join
- Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- Media opacities (cataract) that could decrease visual acuity (VA).
- Previous ocular trauma or vitreoretinal surgery.
- Patients with glaucoma or known to be steroid responders
Trial locations and contacts
1 site in 1 country.
About this study
Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Macular edema (ME) is a major sight-threatening complication of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO and CRVO have the same pathology, an elevation in the intravascular pressure in the occluded vein leading to vascular wall damage causing leakage of fluid and release of inflammatory cytokines as vascular endothelial growth factor (VEGF), respectively.
In the past, the standard treatment for BRVO-related ME was grid laser photocoagulation and for CRVO-related ME was observation. But subsequent randomized controlled trials demonstrated significant functional and anatomical improvements among patients with ME secondary to BRVO or CRVO treated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors or corticosteroids compared to those treated with laser only. Anti-VEGF therapy decrease intravenous pressure, enhance blood flow and improve venous diameter and tortuosity. Also, intravitreal corticosteroid injection has been shown to improve vision and central macular thickness (CMT).
Dexamethasone intravitreal implant (Ozurdex®, Allergan Inc., Irvine, CA, USA) has potent antiangiogenic and anti-inflammatory effects. Also it decreases the vascular permeability playing an important role in treating ME secondary to RVO. However, majority of eyes have been treated previously then shifted to dexamethasone implant as a second line for treatment of refractory RVO related ME.
Read the detailed description
Aim of the research is To evaluate functional and anatomical outcomes of ozurdex injection in patients with RVO related macular edema.
And evaluation of the safety of ozurdex injections regarding intraocular pressure increase, cataract development or endophthalmitis.
Type of the study: Interventional Case Series. Study Setting: Assiut University Hospital (Ophthalmology Department).
Study subjects:
- Inclusion criteria:
- Patients with macular edema secondary to BRVO and CRVO.
- Presence of macular edema >3oo μ on OCT evaluation.
- visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
- Exclusion criteria:
- Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- Media opacities (cataract) that could decrease visual acuity (VA).
- Previous ocular trauma or vitreoretinal surgery.
- Patients with glaucoma or known to be steroid responders.
Baseline evaluation:
- Complete ophthalmic evaluation including assessment of distance BCVA using Snellen charts and will be converted to logarithm of the minimum angle of resolution (logMAR), tonometry, slit-lamp bio microscopy, gonioscopy and dilated fundus examination.
- Thorough clinical history and review of other systems involvement as well as full drug history.
Imaging:
SD-OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) with automated CMT measurements through a dilated pupil.
Color fundus photography and fluorescein angiography will be performed for every patient at baseline to document the clinical appearance and type of RVO using Topcon TRC-NW8F (Topcon Medical Systems, Inc., Tokyo, Japan).
OCTA will be performed before and after injection.
Outcome measures:
Primary (main):
- Assessment of VA and CMT improvement after use of dexamethasone implant in macular edema secondary to RVO.
- Evaluation the safety of intravitreal Ozurdex injection regarding adverse events as IOP increase, cataract development or endophthalmitis.
- Secondary (subsidiary):
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
- To correlate between BCVA and CMT throughout the duration of the study. Data collection: data will recorded in the form of excel spreadsheets. Computer software: SPSS. Statistical tests: Tests of normality will be performed, if data are normally distributed student t-test will be done and if not, Mann-Whitney test will be done.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- Intravitreal injection of Dexamethasone implant
- Keywords
- Dexamethasone Intravitreal Implant, Retinal vein occlusion, Macular Edema
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of Dexamethasone implantDevice
Also called Ozurdex
Intravitreal injection of Dexamethasone implant
| Study group | Role | What they receive |
|---|---|---|
| Patients with RVO | Other | Dexamethasone Intravitreal Implant is used in patients with Macular ar edema due to retinal vein occlusion either from the start or after unsatisfactory response to anti - VEGF Receives: Device: Intravitreal injection of Dexamethasone implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
Measured: 2 years
Secondary outcomes (1)
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
Safety of intravitreal Ozurdex injection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start7 Oct 2021
- Primary completion30 Apr 2023
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menatallah Gamal Saleh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003258
- Sponsor's protocol ID
- FAODIIPMERVO
- Status last verified
- Oct 2023
- First submitted
- 15 Jul 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Teja S, Sawatzky L, Wiens T, Maberley D, Ma P. Ozurdex for refractory macular edema secondary to diabetes, vein occlusion, uveitis and pseudophakia. Can J Ophthalmol. 2019 Oct;54(5):540-547. doi: 10.1016/j.jcjo.2018.12.005. Epub 2019 Jan 25.
PubMed 31564342Maggio E, Mete M, Maraone G, Attanasio M, Guerriero M, Pertile G. Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes. J Ophthalmol. 2020 Feb 13;2020:7817542. doi: 10.1155/2020/7817542. eCollection 2020.
PubMed 32104597
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients with Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
- ClinicalTrials.gov ID
- NCT05003258
- Acronym / sponsor ID
- FAODIIPMERVO
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Keywords
- Dexamethasone Intravitreal Implant, Retinal vein occlusion, Macular Edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 12 Aug 2021 (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.
Retinal vein occlusion (RVO) is one of the most common causes of vision loss due to retinal vascular disease. Incidence of RVO has been raised in the last years due to increased coexisting systemic vascular risk factors as arterial hypertension, obesity, diabetes mellitus and COVID-19. Macular edema (ME) is a major sight-threatening complication of branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO). BRVO and CRVO have the same pathology, an elevation in the intravascular pressure in the occluded vein leading to vascular wall damage causing leakage of fluid and release of inflammatory cytokines as vascular endothelial growth factor (VEGF), respectively.
In the past, the standard treatment for BRVO-related ME was grid laser photocoagulation and for CRVO-related ME was observation. But subsequent randomized controlled trials demonstrated significant functional and anatomical improvements among patients with ME secondary to BRVO or CRVO treated with intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors or corticosteroids compared to those treated with laser only. Anti-VEGF therapy decrease intravenous pressure, enhance blood flow and improve venous diameter and tortuosity. Also, intravitreal corticosteroid injection has been shown to improve vision and central macular thickness (CMT).
Dexamethasone intravitreal implant (Ozurdex®, Allergan Inc., Irvine, CA, USA) has potent antiangiogenic and anti-inflammatory effects. Also it decreases the vascular permeability playing an important role in treating ME secondary to RVO. However, majority of eyes have been treated previously then shifted to dexamethasone implant as a second line for treatment of refractory RVO related ME.
Detailed description
Aim of the research is To evaluate functional and anatomical outcomes of ozurdex injection in patients with RVO related macular edema.
And evaluation of the safety of ozurdex injections regarding intraocular pressure increase, cataract development or endophthalmitis.
Type of the study: Interventional Case Series. Study Setting: Assiut University Hospital (Ophthalmology Department).
Study subjects:
- Inclusion criteria:
- Patients with macular edema secondary to BRVO and CRVO.
- Presence of macular edema >3oo μ on OCT evaluation.
- visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
- Exclusion criteria:
- Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- Media opacities (cataract) that could decrease visual acuity (VA).
- Previous ocular trauma or vitreoretinal surgery.
- Patients with glaucoma or known to be steroid responders.
Baseline evaluation:
- Complete ophthalmic evaluation including assessment of distance BCVA using Snellen charts and will be converted to logarithm of the minimum angle of resolution (logMAR), tonometry, slit-lamp bio microscopy, gonioscopy and dilated fundus examination.
- Thorough clinical history and review of other systems involvement as well as full drug history.
Imaging:
SD-OCT (Spectralis; Heidelberg Engineering, Heidelberg, Germany) with automated CMT measurements through a dilated pupil.
Color fundus photography and fluorescein angiography will be performed for every patient at baseline to document the clinical appearance and type of RVO using Topcon TRC-NW8F (Topcon Medical Systems, Inc., Tokyo, Japan).
OCTA will be performed before and after injection.
Outcome measures:
Primary (main):
- Assessment of VA and CMT improvement after use of dexamethasone implant in macular edema secondary to RVO.
- Evaluation the safety of intravitreal Ozurdex injection regarding adverse events as IOP increase, cataract development or endophthalmitis.
- Secondary (subsidiary):
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
- To correlate between BCVA and CMT throughout the duration of the study. Data collection: data will recorded in the form of excel spreadsheets. Computer software: SPSS. Statistical tests: Tests of normality will be performed, if data are normally distributed student t-test will be done and if not, Mann-Whitney test will be done.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with RVO | Other | Device: Intravitreal injection of Dexamethasone implantDexamethasone Intravitreal Implant is used in patients with Macular ar edema due to retinal vein occlusion either from the start or after unsatisfactory response to anti - VEGF |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with macular edema secondary to BRVO and CRVO.
- Presence of macular edema >3oo μ on OCT evaluation.
- visual acuity of +0.3 logarithm of the minimum angle of resolution (logMAR) or worse.
Key exclusion criteria (4 listed)
- Presence of coexisting retinal disease (such as diabetic retinopathy, age related macular degeneration, vitreo-macular traction, or epiretinal membrane).
- Media opacities (cataract) that could decrease visual acuity (VA).
- Previous ocular trauma or vitreoretinal surgery.
- Patients with glaucoma or known to be steroid responders
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 |
|---|---|---|
| Intravitreal injection of Dexamethasone implantAlso: OzurdexIntravitreal injection of Dexamethasone implant | Device | Patients with RVO |
Primary outcome
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO.
Time frame: 2 years
1 secondary outcome
- To evaluate the incidence and onset of occurrence of any adverse event or recurrence.
Time frame: 2 years
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 22 Jan 2025.
- Background: PubMed 31564342Teja S, Sawatzky L, Wiens T, Maberley D, Ma P. Ozurdex for refractory macular edema secondary to diabetes, vein occlusion, uveitis and pseudophakia. Can J Ophthalmol. 2019 Oct;54(5):540-547. doi: 10.1016/j.jcjo.2018.12.005. Epub 2019 Jan 25.
- Background: PubMed 32104597Maggio E, Mete M, Maraone G, Attanasio M, Guerriero M, Pertile G. Intravitreal Injections for Macular Edema Secondary to Retinal Vein Occlusion: Long-Term Functional and Anatomic Outcomes. J Ophthalmol. 2020 Feb 13;2020:7817542. doi: 10.1155/2020/7817542. eCollection 2020.
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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 study testing Intravitreal injection of Dexamethasone implant in people with Macular Edema and Retinal Vein Occlusion, run by Assiut 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 4 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 22 Jan 2025. 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.
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?
_Assessment of VA using snellen chart after use of ozurdex in macular edema secondary to RVO. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003258, which also lists 2 linked publications.
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 22 Jan 2025.