Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema

NCT04387604 | Completed

• 1 other identifier: 2017080120190301
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE: To evaluate the effect of the vitreous in response to intravitreal (IV) injections of ranibizumab 0.5 mg/0.05ml (Lucentis; Genentech, South San Francisco, CA) for the treatment of diabetic macular edema (DME). METHODS: Prospective, observational, multicenter study, conducted at Centro Hospitalar e Universitário do Porto, Portugal. Best-corrected visual acuity and central foveal thickness will be evaluated at baseline and every month until the end of follow-up. OCT biomarkers such as retinal layers thickness will also be analyzed. A p value of 0.05 or less will be considered to be statistically significant. HYPOTHESIS: Vitrectomized patients will improve less than non-vitrectomized patients.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• assess the number of IV injections needed to control DME between groups

  DME control is defined as 1) BCVA of 85 letters and OCT CFT "normal" (CFT≤300 μm and non-existent intra- or sub-retinal fluid); or 2) OCT CFT "normal" (CFT≤300 μm) and stable BCVA (defined as \<5 letters change from last injection) after two consecutive injections during the first 24 weeks, or after one injection if the initial stability period has already been achieved (OCT CFT "normal" and stable BCVA).

  18 months

Secondary Outcomes (5)

• compare the functional changes at the end of follow-up between groups

  18 months

• compare the anatomical changes at the end of follow-up between groups

  18 months

• compare the percentage of type of responder during the follow-up period between groups

  18 months

• access the percentage, in group 2, of focal VMA and PVD status and type of response

  18 months

• assess retinal layers thickness as prognostic and pathophysiological biomarkers of DME treatment response

  18 months

Study Arms (2)

non vitrectomized eyes

ranibizumab injections (0.5 mg/0.05ml) following a PRN regimen

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

vitrectomized eyes

ranibizumab injections (0.5 mg/0.05ml) following a PRN regimen

Drug: Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]

Interventions

Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS] DRUG

PRN regimen. Treatment Schedule Repeat injections at every 4-week visit if eye "improves" or "worsens" (defined as ≥5 letter change from last injection or ≥10% CST change on OCT from last injection or CSF\>300 μm at any timepoint). Defer injections if either BCVA of 85 letters and OCT CSF "normal" (CSF≤300 μm and non-existent intra- or sub-retinal fluid); or OCT CSF "normal" (CSF≤300 μm) and stable BCVA (defined as \< 5 letters change from last injection) after two consecutive injections during the first 24 weeks, or after one injection if the initial stability period has already been achieved (OCT CSF "normal" and stable BCVA). Resume injections if BCVA or OCT worsens.

non vitrectomized eyes; vitrectomized eyes

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with DME followed on the ocular diabetes consultation of Centro Hospitalar e Universitário do Porto, Portugal, or Hospital Santa Maria Maior de Barcelos, Portugal, either non vitrectomized or vitrectomized.

You may qualify if:

• at least 18 years of age with either type 1 or type 2 diabetes mellitus;
• maximal central subfield foveal thickness (CSF) of at least 300μm (according to SD-OCT images - Spectral Domain Optical Coherence Tomography);
• BCVA of 20 to 80 letters, using ETDRS letters chart;
• ability to provide written informed consent.

You may not qualify if:

• Pregnant or lactating;
• Epiretinal membrane (ERM) existence in the study eye;
• persistent posterior hyaloid adherence after vitrectomy for group 2;
• previous vitrectomy for group 1;
• history of other retinal vascular diseases in the study eye;
• history of IV of implant of fluocinolone acetonide in the study eye;
• vitreous hemorrhage or opacification in the study eye;
• active proliferative diabetic retinopathy in the study eye;
• active ocular inflammation or infection in either eye;
• aphakia in the study eye;
• other causes for macular edema, for example, after cataract surgery in the study eye;
• other causes of visual loss in the study eye;
• other diseases that may affect the course of macular edema in the study eye;
• uncontrolled glaucoma in either eye (intraocular pressure \> 24 mmHg with treatment);
• history of arterial thrombotic event in the previous 6 months;

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead

Study Sites (1)

Hospital de Santo António

Porto, Portugal

Location

Related Publications (3)

• Pessoa B, Leite J, Ferreira A, Ramalhao J, Pocas J, Jose D, Coelho C, Figueira J, Meireles A, Beirao JM. Oct biomarkers for early prognosis in diabetic macular edema treatment with ranibizumab. Eur J Ophthalmol. 2024 Jul;34(4):1141-1148. doi: 10.1177/11206721231210753. Epub 2023 Nov 3.

  PMID: 37919940 DERIVED

• Pessoa B, Leite J, Heitor J, Coelho J, Monteiro S, Coelho C, Figueira J, Meireles A, Melo-Beirao JN. Vitrectomized versus non-vitrectomized eyes in diabetic macular edema response to ranibizumab-retinal layers thickness as prognostic biomarkers. Sci Rep. 2021 Nov 29;11(1):23055. doi: 10.1038/s41598-021-02532-4.

  PMID: 34845300 DERIVED

• Pessoa B, Marques JH, Leite J, Silva N, Jose D, Coelho C, Figueira J, Meireles A, Melo-Beirao JN. Choroidal Blood Flow After Intravitreal Ranibizumab in Vitrectomized and Non-Vitrectomized Eyes with Diabetic Macular Edema. Clin Ophthalmol. 2021 Oct 9;15:4081-4090. doi: 10.2147/OPTH.S325037. eCollection 2021.

  PMID: 34675476 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bernardete Pessoa, MD

  Centro Hospitalar e Universitário do Porto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Specialist Vitreoretinal Surgeon

Study Record Dates

• First Submitted: May 10, 2020
• First Posted: May 14, 2020
• Study Start: August 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 1, 2019
• Last Updated: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)