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Macular EdemaPhase 1/2DDS-25NCT01662518

DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

A Phase 1/2 study testing Dexamethasone drug delivery system (DDS-25) in people with Macular Edema and Retinal Vein Occlusion, run by Centro de Pesquisa Rubens Siqueira at 1 site in Brazil.

Completed

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

Official record
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Trial summary

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
Dexamethasone drug delivery system (DDS-25)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteBrazil
Study dates
Jul 2011to Jun 2016
Phase
Phase 1/2
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

  • 18 years of age or older with macular edema resulting from retinal vein occlusion
  • Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
  • Visual acuity in other eye no worse than 20/200

Who cannot join

  • Known anticipated need for ocular surgery within next 12 months
  • History of glaucoma or current high eye pressure requiring more than 1 medication
  • Diabetic retinopathy
  • Uncontrolled systemic disease
  • Known steroid-responder
  • Use of systemic steroids
  • Use of warfarin/heparin

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Centro de Pesquisa Rubens Siqueira

    São José do Rio Preto, São Paulo, 15010-100

Other trials in Brazil

About this study

Official title: A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.

Read the detailed description

Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).

Being tested
Dexamethasone drug delivery system (DDS-25)
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.

  • Dexamethasone drug delivery system (DDS-25)Device

    350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline

Study groups in NCT01662518
Study groupRoleWhat they receive
DDS-25ExperimentalIntravitreal injection of DDS-25(Dexamethasone drug delivery system )
Receives: Device: Dexamethasone drug delivery system (DDS-25)

What is being measured

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

  1. Best Corrected Visual Acuity (BCVA)

    Measured: Day 0 - Day 180

Secondary outcomes (1)

  1. Change in central foveal thickness at 48 weeks

    Measured: 1 day to 48 weeks

Timeline

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

  1. First posted10 Aug 2012 (estimated)
  2. Study startJul 2011
  3. Primary completionJan 2016
  4. Study completionJun 2016

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01662518
Sponsor's protocol ID
Bramets-01
Acronym
DDS-25
Status last verified
Jan 2017
First submitted
8 Aug 2012
Last updated
1 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Retin Cases Brief Rep. 2016 Sep 14. \[Epub ahead of print\] SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL. Cunha RB1, Siqueira RC, Messias A, Scott IU, Fialho SL, Cunha-Junior AD, Jorge R.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dexamethasone drug delivery system (DDS-25) in people with Macular Edema and Retinal Vein Occlusion, run by Centro de Pesquisa Rubens Siqueira at 1 site in Brazil.

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 7 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 1 Feb 2017. 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 Brazil. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Best Corrected Visual Acuity (BCVA) (time frame: Day 0 - Day 180). 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 NCT01662518.

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 1 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.

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