NCT03944070

Brief Summary

To-date there have been only very few studies to examine the effect of cataract surgery to patients with wet age-related macular degeneration. The evidence on the effects of cataract surgery in such patients suggests improvement of their visual function and quality of life, but at the same time a subclinical susceptibility to macular edema and exacerbation of the choroidal neovascularization. Therefore it is highly important to identify the optimum treatment regime, pursuing the best anatomical and functional postoperative results.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

May 9, 2019

Status Verified

May 1, 2019

Enrollment Period

2 years

First QC Date

April 23, 2019

Last Update Submit

May 8, 2019

Conditions

Wet Macular DegenerationCataract Extraction

Outcome Measures

Primary Outcomes (2)

  • Visual acuity change from baseline

    Difference in visual acuity change from baseline at the end of the follow-up period.

    12 months

  • Difference in the number of injections

    Difference in the number of injections at the end of the follow-up period.

    12 months

Secondary Outcomes (1)

  • Status of the macular degeneration based on optical coherence tomography parameter, as compared to baseline

    12 months

Study Arms (2)

Intensive Treatment

ACTIVE COMPARATOR

The participants will receive x1 intraoperative and 3 postop monthly injections. Subsequently, they will follow the treat and extend protocol.

Drug: Ranibizumab

Standard Treatment

ACTIVE COMPARATOR

The participants will continue their preoperative treat and extend protocol .

Drug: Ranibizumab

Interventions

RanibizumabDRUG

Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.

Also known as: Lucentis
Intensive TreatmentStandard Treatment

Eligibility Criteria

Age50 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active choroidal neovascularization (at least 1 intravitreal injection in the past 12 months) associated with AMD and involving the foveal center
  • BCVA of 1.0 (LogMAR) or better
  • Duration of wet AMD less than 3 years

You may not qualify if:

  • Coexisting ocular pathology potentially affecting visual acuity and/or status of the macula including diabetic retinopathy, advanced glaucoma, retinal vein occlusion, retinal detachment
  • Newly diagnosed patients with wet AMD who are on anti-VEGF treatment for less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmica Eye Institute

Thessaloniki, Kalamaria, 54655, Greece

RECRUITING

Related Publications (2)

  • Kessel L, Erngaard D, Flesner P, Andresen J, Tendal B, Hjortdal J. Cataract surgery and age-related macular degeneration. An evidence-based update. Acta Ophthalmol. 2015 Nov;93(7):593-600. doi: 10.1111/aos.12665. Epub 2015 Jan 20.

    PMID: 25601333BACKGROUND

  • Saraf SS, Ryu CL, Ober MD. The effects of cataract surgery on patients with wet macular degeneration. Am J Ophthalmol. 2015 Sep;160(3):487-492.e1. doi: 10.1016/j.ajo.2015.06.006. Epub 2015 Jun 19.

    PMID: 26095263BACKGROUND

MeSH Terms

Conditions

Wet Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Paris G Tranos, PhD

    Head of Uveitis & Retinal Surgery Department, Ophthalmica Eye Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paris G Tranos, PhD

CONTACT

00302310263063tranos@ophthalmica.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2019

First Posted

May 9, 2019

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

May 9, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)