Diabetic Macular EdemaNCT05731089
IVI Aflibercept Before and After Phaco in DME.
A study testing Phacoemulsification with IVI of aflibercept in people with Diabetic Macular Edema, run by Al Hadi Hospital at 1 site in Kuwait.
Trial summary
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Phacoemulsification with IVI of aflibercept
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteKuwait
- Study dates
- 1 Sep 2019to 1 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic patients with visually significant cataract
Who cannot join
- previous vitreoretinal surgery
- laser or intravitreal injections 6 months prior to the procedure
- intractable glaucom
- active intra-ocular inflammation
- retinal detachment
- vitreous hemorrhage
Show all 9Show fewer
- epi-retinal membranes
- any other retinal vascular or neuroretinal disease.
- Patients with eventual cataract surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
Read the detailed description
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.
- Conditions
- Diabetic Macular Edema
- Being tested
- Phacoemulsification with IVI of aflibercept
- Keywords
- Aflibercept; cataract; diabetic macular edema
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with IVI of afliberceptProcedure or surgery
IVI was either before or after cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | Patients in group A were planned to defer the cataract surgery until receiving two injections of Aflibercept at monthly interval, the third injection was then given intra-operatively. Receives: Procedure: Phacoemulsification with IVI of aflibercept |
| group B | Active comparator | Patients in group B were planned to undergo cataract surgery first and received the first injection intra-operatively, then received two post-operative injections with a monthly interval. Receives: Procedure: Phacoemulsification with IVI of aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
resolving of macular edema
change in central macular thickness
Measured: Sixth month
Secondary outcomes (1)
Improvement of visual acuity
measuring of BCVA
Measured: Sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Sep 2019
- Primary completion1 Aug 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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
- prospective
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al Hadi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer MohamedSadeck Khattab, Al Hadi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731089
- Sponsor's protocol ID
- IVI and phaco
- Status last verified
- Feb 2023
- First submitted
- 4 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khattab AM, Hagras SM, Lotfy NM. Pre-operative versus post-operative intravitreal aflibercept injection for management of DME in patients undergoing cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3223-3229. doi: 10.1007/s00417-023-06138-6. Epub 2023 Jun 17.
PubMed 37329361
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Versus Post-Operative Intravitreal Aflibercept Injection for Management of DME in Patients Undergoing Cataract Surgery
- ClinicalTrials.gov ID
- NCT05731089
- Acronym / sponsor ID
- IVI and phaco
- Conditions
- Diabetic Macular Edema
- Keywords
- Aflibercept; cataract; diabetic macular edema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Al Hadi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Feb 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.
To study whether or not cataract surgery should be deferred until treating the co-existing diabetic macular edema (DME) using intravitreal (IVI) anti-vascular endothelial growth factor (anti-VEGF).
Detailed description
A prospective randomized interventional study included diabetic patients with visually significant cataract and DME. Patients were divided into 2 groups. Group A received three pre-operative intravitreal Aflibercept injections with a monthly interval, the third injection was given intra-operatively. Group B received a single intra-operative injection, and two post-operative injections with a monthly interval. follow up for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Procedure: Phacoemulsification with IVI of afliberceptPatients in group A were planned to defer the cataract surgery until receiving two injections of Aflibercept at monthly interval, the third injection was then given intra-operatively. |
| group B | Active comparator | Procedure: Phacoemulsification with IVI of afliberceptPatients in group B were planned to undergo cataract surgery first and received the first injection intra-operatively, then received two post-operative injections with a monthly interval. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients with visually significant cataract
Key exclusion criteria (9 listed)
- previous vitreoretinal surgery
- laser or intravitreal injections 6 months prior to the procedure
- intractable glaucom
- active intra-ocular inflammation
- retinal detachment
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 |
|---|---|---|
| Phacoemulsification with IVI of afliberceptIVI was either before or after cataract surgery | Procedure or surgery | group A, group B |
Primary outcome
resolving of macular edema
Time frame: Sixth month
change in central macular thickness
1 secondary outcome
Improvement of visual acuity
Time frame: Sixth month
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 16 Feb 2023.
- Derived from this study: PubMed 37329361Khattab AM, Hagras SM, Lotfy NM. Pre-operative versus post-operative intravitreal aflibercept injection for management of DME in patients undergoing cataract surgery. Graefes Arch Clin Exp Ophthalmol. 2023 Nov;261(11):3223-3229. doi: 10.1007/s00417-023-06138-6. Epub 2023 Jun 17.
- 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 study testing Phacoemulsification with IVI of aflibercept in people with Diabetic Macular Edema, run by Al Hadi Hospital at 1 site in Kuwait.
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 1 inclusion and 9 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 16 Feb 2023. 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 Kuwait. 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?
resolving of macular edema (time frame: Sixth month). 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 NCT05731089, which also lists 1 linked publication.
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 16 Feb 2023.