Ranibizumab Versus Dexamethasone Implant in Diabetic Macular Edema

An observational study of Diabetic Macular Edema, run by G. d'Annunzio University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Between December 2016 and June 2017 a total of 40 eyes from 40 diabetic retinopathy patients with diabetic macular edema were recruited at the Ophthalmologic Clinic of University "G. d'Annunzio", Chieti-Pescara, Italy. Read more about this study

Who is it for?: Ages 19 to 90 years
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Dexamethasone intravitreal implant 0.7 mg and Ranibizumab Injection
Type of treatment: Injection or infusion
How many people: 40 participants
Where: No sites listed yet
Study dates: 6 Dec 2016to 27 Jun 2017
Phase: Observational
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 19 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with no proliferative moderate DR stage (simplified version of the ETDRS classification aimed by the American Academy of Ophthalmology Guidelines Committe) and cystoid macular edema type without subretinal fluid component were recruited

Who may be able to join

Age >18 years old
BCVA greater than 0.5 LogMAR in the study eye at baseline examination
Presence of recent DME
CMT > 300µm as measured using the SD-OCT at the baseline examination

Who cannot join

Any previous ocular surgery in the last 6 months
Laser treatments
Prior ocular trauma
Retinal vascular diseases
Vitreo-retinal interface diseases
Medium lens opacities (according to Lens Opacities Classification System)

About this study

Official title: Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up

Conditions: Diabetic Macular Edema
Being tested: Dexamethasone intravitreal implant 0.7 mg, Ranibizumab Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dexamethasone intravitreal implant 0.7 mgDrug
Intravitreal Implant of dexamethasone
Ranibizumab InjectionDrug
Injection of ranibizumab

Study groups in NCT03385382
Study group	Role	What they receive
Dexamethasone group		Patients with diabetic macular edema receiving dexamethasone Receives: Drug: Dexamethasone intravitreal implant 0.7 mg
ranibizumab		Patients with diabetic macular edema receiving ranibizumab Receives: Drug: Ranibizumab Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Central macular thickness
Decrease of macular thickness
Measured: 6 months

Secondary outcomes (1)

visual acuity
Increase of mean visual acuity
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Dec 201627 Jun 2017

First posted28 Dec 2017
Study start6 Dec 2016
Primary completion27 Jun 2017
Study completion27 Jun 2017

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.
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: Other
Time perspective: Other
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03385382
Sponsor's protocol ID: UChieti
Acronym: LED
Status last verified: Dec 2017
First submitted: 20 Dec 2017
Last updated: 2 Jan 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Yes by request to the investigator via email

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Macular Thickness and Vessel Density Changes After Dexamethasone Implant and Ranibizumab Intravitreal Injection in Diabetic Macular Edema: 6-month Follow-up
ClinicalTrials.gov ID: NCT03385382
Acronym / sponsor ID: LED / UChieti
Conditions: Diabetic Macular Edema
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: G. d'Annunzio UniversityUniversity, hospital or other
Study start: 6 Dec 2016 (actual)
Primary completion: 27 Jun 2017 (actual)
Study completion: 27 Jun 2017 (actual)
First posted: 28 Dec 2017 (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.

Study design

Observational model: Other
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Dexamethasone group	–	Drug: Dexamethasone intravitreal implant 0.7 mgPatients with diabetic macular edema receiving dexamethasone
ranibizumab	–	Drug: Ranibizumab InjectionPatients with diabetic macular edema receiving ranibizumab

Who may qualify

Ages: 19 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with no proliferative moderate DR stage (simplified version of the ETDRS classification aimed by the American Academy of Ophthalmology Guidelines Committe) and cystoid macular edema type without subretinal fluid component were recruited

Key inclusion criteria (4 listed)

Age >18 years old
BCVA greater than 0.5 LogMAR in the study eye at baseline examination
Presence of recent DME
CMT > 300µm as measured using the SD-OCT at the baseline examination

Key exclusion criteria (6 listed)

Any previous ocular surgery in the last 6 months
Laser treatments
Prior ocular trauma
Retinal vascular diseases
Vitreo-retinal interface diseases

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
Dexamethasone intravitreal implant 0.7 mgIntravitreal Implant of dexamethasone	Drug	Dexamethasone group
Ranibizumab InjectionInjection of ranibizumab	Drug	ranibizumab

Primary outcome

Central macular thickness
Time frame: 6 months
Decrease of macular thickness

1 secondary outcome

visual acuity
Time frame: 6 months

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 2 Jan 2018.
Individual participant dataSharing planned: No. Yes by request to the investigator via email

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema, run by G. d'Annunzio University.

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 4 inclusion and 6 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 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Central macular thickness (time frame: 6 months). 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 NCT03385382.

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 2 Jan 2018.