Clinical Trials Logo
  1. Home
  2. Macular Edema
  3. NCT02623673
  4. Details
NCT02623673 Clinical Trial

Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Macular Edema Clinical Trial

Official title:
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02623673
Other study ID # Retina CLINIC
Secondary ID
Status Completed
Phase N/A
First received December 3, 2015
Last updated February 14, 2016
Start date September 2015
Est. completion date February 2016

Study information
Verified date February 2016
Source Retina Clinic, Sao Paulo, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

Retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) of patients diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and implant of dexamethasone 0.7mg.

Description:

This retrospective cases series is a non-randomized, open-label, single-center investigation (Retina Clinic, São Paulo, Brazil) approved by the Institutional Review Board of Hospital Oftalmológico de Sorocaba/SP, and adhered to the tenets of the Declaration of Helsinki. Were included patients older than 18 years, treated between April 2014 and July 2015, diagnosed with macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions who underwent to simultaneous treatment with intravitreal injection of bevacizumab 1.25mg (Avastin; Genentech, South San Francisco, CA) and intravitreal implant of dexamethasone 0.7mg (Ozurdex; Allergan, Inc, Irvine, CA).

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date February 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- central macular thickness > 300 µm on optical coherence tomography (OCT)

- macular edema secondary to diabetic retinopathy (DME) and retinal vein occlusions

Exclusion Criteria:

- intravitreal anti-VEGF within 6 weeks

- treatment with laser or intravitreal corticosteroids within 3 months of study entry.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.

Locations
Country Name City State
Brazil Retina Clinic / UNIFESP São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Retina Clinic, Sao Paulo, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Improvement in BCVA 6 months No
See also
  Status Clinical Trial Phase
Completed NCT04292912 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema Phase 1
Recruiting NCT05976139 - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies N/A
Completed NCT03660345 - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME Phase 3
Completed NCT03660371 - ILM Peeling in PDR Patients Undergoing PPV for VH N/A
Completed NCT01660802 - Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO) Phase 3
Completed NCT01908816 - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases. Phase 3
Completed NCT04592419 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Terminated NCT01946399 - Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF N/A
Completed NCT01428388 - Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion N/A
Completed NCT01231633 - Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO) N/A
Recruiting NCT01023113 - To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation N/A
Terminated NCT00969293 - Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion Phase 1
Completed NCT00970957 - Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion Phase 3
Terminated NCT00918554 - Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis Phase 4
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Completed NCT00668239 - Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser N/A
Completed NCT00411970 - 20- Versus 23- Gauge System for Pars Plana Vitrectomy Phase 4
Terminated NCT01939691 - Macular Edema Nepafenac vs. Difluprednate Uveitis Trial Phase 4
Active, not recruiting NCT04120311 - Episcleral Dexamethasone for Treatment of Macular Edema and Inflammatory Disorders of the Posterior Pole Phase 1