Diabetic Vitreous HemorrhagePhase 4NCT04153253
Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage
A Phase 4 study testing Aflibercept Injection [Eylea] and Vitrectomy in people with Diabetic Vitreous Hemorrhage, run by Al Hadi Hospital at 1 site in Kuwait.
Trial summary
Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Vitreous Hemorrhage
- What is being tested?
- Aflibercept Injection [Eylea] and Vitrectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteKuwait
- Study dates
- 7 Mar 2018to 29 Sep 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years.
- Any sex.
- Type Ι or ΙΙ DM,
- recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
- BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).
Who cannot join
- Tractional retinal detachment.
- Previous PRP.
- History of anti VEGF therapy within the past two months.
- Neovascular glaucoma
- Subhyaloid hemorrhage.
- Vitreomacular traction.
- Diabetic macular edema .
- Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage
Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.
Read the detailed description
Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.
- Conditions
- Diabetic Vitreous Hemorrhage
- Being tested
- Aflibercept Injection [Eylea], Vitrectomy
- Keywords
- Aflibercept, panretinal photocoagulation, vitrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Injection [Eylea]Drug
Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception).
PRP was done if the hemorrhage is sufficiently cleared after the third injection.
VitrectomyProcedure or surgery
Was done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Intravitreal injection of Aflibercept followed by panretinal photocoagulation. Receives: Drug: Aflibercept Injection [Eylea] |
| Group II: Early vitrectomy. | Active comparator | Early vitrectomy. Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean best corrected visual acuity(BCVA) change in both groups.
Final BCVA change measured in log MAR compared to initial BCVA.
Measured: 9 months follow up.
Secondary outcomes (2)
Rate of recurrent bleeding.
Rate of recurrent vitreous hemorrhage in both groups after initial clearance.
Measured: 9 months follow up.
Number of additional treatment procedures .
Additional treatment procedures done in cases of recurrent hemorrhage in both groups.
Measured: 9 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start7 Mar 2018
- Primary completion22 Jul 2019
- Study completion29 Sep 2019
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 Vitreous HemorrhageStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- Investigators
- Ahmed H Abdelhamid, MD, Study director, Alhadi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04153253
- Sponsor's protocol ID
- 003-19
- Status last verified
- Jan 2020
- First submitted
- 4 Nov 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be given from the author upon request.
Publications
Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.
PubMed 32252674
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Aflibercept Injection With Panretinal Photocoagulation Versus Early Vitrectomy for Diabetic Vitreous Hemorrhage
- ClinicalTrials.gov ID
- NCT04153253
- Acronym / sponsor ID
- 003-19
- Conditions
- Diabetic Vitreous Hemorrhage
- Keywords
- Aflibercept, panretinal photocoagulation, vitrectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Al Hadi HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 22 Jul 2019 (actual)
- Study completion
- 29 Sep 2019 (actual)
- First posted
- 6 Nov 2019 (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.
Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.
Detailed description
Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Aflibercept Injection [Eylea]Intravitreal injection of Aflibercept followed by panretinal photocoagulation. |
| Group II: Early vitrectomy. | Active comparator | Procedure: VitrectomyEarly vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 18 years.
- Any sex.
- Type Ι or ΙΙ DM,
- recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
- BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).
Key exclusion criteria (8 listed)
- Tractional retinal detachment.
- Previous PRP.
- History of anti VEGF therapy within the past two months.
- Neovascular glaucoma
- Subhyaloid hemorrhage.
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 |
|---|---|---|
| Aflibercept Injection [Eylea]Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception). PRP was done if the hemorrhage is sufficiently cleared after the third injection. | Drug | Group I |
| VitrectomyWas done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment. | Procedure or surgery | Group II: Early vitrectomy. |
Primary outcome
Mean best corrected visual acuity(BCVA) change in both groups.
Time frame: 9 months follow up.
Final BCVA change measured in log MAR compared to initial BCVA.
2 secondary outcomes
Rate of recurrent bleeding.
Time frame: 9 months follow up.
Number of additional treatment procedures .
Time frame: 9 months follow up
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 14 Jan 2020.
- Derived from this study: PubMed 32252674Abd Elhamid AH, Mohamed AAEA, Khattab AM. Intravitreal Aflibercept injection with Panretinal photocoagulation versus early Vitrectomy for diabetic vitreous hemorrhage: randomized clinical trial. BMC Ophthalmol. 2020 Apr 6;20(1):130. doi: 10.1186/s12886-020-01401-4.
- Individual participant dataSharing planned: Undecided. The data will be given from the author upon request.
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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.
Ahmed H Abdelhamid, MD study director
Alhadi hospital
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 Aflibercept Injection [Eylea] and Vitrectomy in people with Diabetic Vitreous Hemorrhage, 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 5 inclusion and 8 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 14 Jan 2020. 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.
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?
Mean best corrected visual acuity(BCVA) change in both groups. (time frame: 9 months follow up.). 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 NCT04153253, 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 14 Jan 2020.