NCT04377295

Brief Summary

This study evaluates the retinal and vascular features in patients with radiation maculopathy under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2012

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

6.9 years

First QC Date

May 3, 2020

Last Update Submit

May 3, 2020

Conditions

Radiation Maculopathy

Outcome Measures

Primary Outcomes (2)

  • Study of retinal and vascular features in pazients affected by radiation maculopathy after intravitreal injections of Ranibizumab

    The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography (OCT). The parameter analyzed by OCT was: Central Macular Thickness (micron).

    one year

  • Study of retinal and vascular features in patients affected by radiation maculopathy after intravitreal injections of Ranibizumab

    The effectiveness of Ranibizumab injections for treating radiation maculopathy using optical coherence tomography angiography (OCTA). The parameter analyzed by OCTA was: retinal vessel density (%)

    one year

Interventions

Ranibizumab 0.5Mg/0.05Ml Oph InjDRUG

All patients received one monthly intravitreal injection of Ranibizumab (0.5 mg/0.05 ml) through the pars plana under aseptic conditions until maximum visual acuity was achieved and there was no sign of macular edema at optical coherence tomography

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The participans were older than 40 years with diagnosis of radiation maculopathy. They did not present other ophthalmological diseases.

You may qualify if:

  • age older than 40 years
  • diagnosis of radiation maculopathy
  • treatment-naïve with Ranibizumab
  • absence of other vitreoretinal and vascular retinal diseases

You may not qualify if:

  • age younger than 40 years
  • No diagnosis of radiation maculopathy
  • previous treatments with Ranibizumab
  • presence of vitreoretinal and vascular retinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gilda Cennamo

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 6, 2020

Study Start

October 30, 2012

Primary Completion

October 1, 2019

Study Completion

October 30, 2019

Last Updated

May 6, 2020

Record last verified: 2020-05