SD-OCT-guided Intravitreal Ranibizumab Treatment in Choroidal Neovascularization Due to Myopia

NCT03409250 | Completed Phase 4

• 1 other identifier: MYOPIE-2011-04
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This investigator initiated pilot study is designed to investigate the efficacy and safety of SD-OCT-guided intravitreal ranibizumab treatment in choroidal neovascularization (CNV) due to myopia. Newly diagnosed and active CNVs due to myopia are treated with one intravitreal injection of Ranibizumab 0.5mg (Lucentis) at baseline. During the follow up period of 12 months monthly ophthalmological examinations including best corrected visual acuity (BCVA) and high resolution spectral-domain optical coherence tomography (SD-OCT) assessments are performed. Detection of persisting or new signs of CNV activity at OCT triggers ranibizumab re-treatment considering that any ranibizumab injections can maximally be applied as often as monthly.

Conditions

Choroidal Neovascularization; Age Related Macular Degeneration

Keywords

CNV due to Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• BCVA

  SD-OCT-guided intavitreal ranibizumab treatment in CNV due to myopiea may prevent vision loss as evaluated as change in BCVA from Baseline.

  Baseline to 12-months

Secondary Outcomes (5)

• BCVA change from Baseline to month 12

  Baseline to month 12

• Treatments from Baseline to month 12

  Baseline to month 12

• OCT changes from Baseline to month 12

  Baseline to month 12

• Fluo changes from Baseline to month 12

  Baseline to month 12

• Ranibizumab tolerability from Baseline to month 12

  Baseline to month 12

Study Arms (1)

1-Arm study

OTHER

prospective, 1-arm, monocenter, investigator initiated study Intravitreal injection with Lucentis (Ranibizumab)

Drug: Ranibizumab, Lucentis

Interventions

Ranibizumab, Lucentis DRUG

Intravitreal injection with Lucentis (Ranibizumab)

Also known as: Intravitreal injection with Lucentis (Ranibizumab)

1-Arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients ≥ 18 years of age.
• Patients with active primary sub- or juxtafoveal CNV secondary to myopia.
• Evidence that CNV extends under the geometric center of the foveal avascular zone or in case of juxtafoveal lesions there is evidence that leakage from CNV extends under the geometric center of the foveal avascular zone as proven by fluorescein angiography.
• The total area of CNV encompassed within the lesion must be ≥ 50% of the total lesion area.
• The total lesion area ≤ 12 disc areas for minimally classic or occult with no classic component and ≤ 9 disc areas (5400µm) in greatest linear dimension with predominantly classic lesions.
• Patients who have a BCVA of ≥ 20/200 (letter score of ≥ 23 letters) in the study eye using ETDRS charts.
• Willing and able to comply with study procedures.

You may not qualify if:

• Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1 disc area in size.
• Structural damage to the center of the macula (beside CNV) in the study eye likely to preclude improvement in visual acuity, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), or organized hard exudate plaques.
• Presence of a retinal pigment epithelial tear involving the macula in the study eye.
• Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
• Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
• Active intraocular inflammation (grade trace or above) in the study eye.
• Any active infection involving ocular adnexa including infectious conjunctivitis, keratitis, scleritis, endophthalmitis, as well as idiopathic or autoimmune-associated uveitis in either eye.
• History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
• Aphakia with absence of the posterior capsule in the study eye.
• Any prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, transpupillary thermotherapy, intravitreally applied drugs.
• History of submacular surgery in the study eye, glaucoma filtration surgery, corneal transplant surgery.
• Extracapsular extraction of cataract with phacoemulsification within three months preceding Baseline, or a history of post-operative complications within the last 12 months preceding Baseline in the study eye (uveitis, cyclitis, etc.).
• Use of other investigational drugs at the time of baseline, or within 30 days or 5 half- lives of baseline, whichever is longer (excluding vitamins and minerals).
• Previous violation of the posterior capsule in the study eye unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.
• History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.

Sponsors & Collaborators

• Vista Klinik: lead

Study Sites (1)

Vista Klinik

Binningen, Basel-Landschaft, 4102, Switzerland

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Ranibizumab; Intravitreal Injections

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Injections, Intraocular; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Christian Pruente, MD

  Vista Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Katja Hatz

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: January 24, 2018
• Study Start: June 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

CH (1)