Choroidal NeovascularizationPhase 3ECLIPSENCT01908816

An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.

A Phase 3 study testing ranibizumab in people with Choroidal Neovascularization and Macular Edema, run by Novartis Pharmaceuticals at 39 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular
What is being tested?: ranibizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 39 sitesFrance
Study dates: 26 Sep 2013to 8 Jan 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Active choroidal neovascularization (CNV)
Active macular edema (ME)
Rubeosis iridis/neovascular glaucoma.
Proliferative diabetic retinopathy requiring vitrectomy.

Who cannot join

wet Age-related macular degeneration
pathologic myopia
pseudoxanthoma elasticum
diabetic macular edema
retinal vein occlusion
< 18 years of age

Show all 10Show fewer

History of hypersensitivity to ranibizumab
Use of any systemic anti-angiogenic drugs 3 months before inclusion
Women of child-bearing potential and Pregnant or nursing (lactating) women.
Active or suspected ocular infection

Trial locations and contacts

39 sites in 1 country.

City, postcode or hospital

39 sites in 1 country

France39 sites

Novartis Investigative Site
Amiens, 80054
Novartis Investigative Site
Angers, 49044
Novartis Investigative Site
Bobigny, Seine Saint Denis, 93009
Novartis Investigative Site
Bordeaux, 33000
Novartis Investigative Site
Bordeaux, 33100
Novartis Investigative Site
Caen, 14050
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Écully, 69130
Novartis Investigative Site
Grenoble, 38000
Novartis Investigative Site
Grenoble, 38043
Novartis Investigative Site
Lille, 59000
Novartis Investigative Site
Lyon, 69275
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Mantes-la-Jolie, 78201
Novartis Investigative Site
Marseille, 13008
Novartis Investigative Site
Marseille, F 13008
Novartis Investigative Site
Melun, 77000
Novartis Investigative Site
Montauban, 82000
Novartis Investigative Site
Montpellier, 34000
Novartis Investigative Site
Mulhouse, 68070
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 06000
Novartis Investigative Site
Paris, 75006
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Paris, 75014
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, 75940
Novartis Investigative Site
Paris, F-75571
Novartis Investigative Site
Poitiers, 86021
Novartis Investigative Site
Rouen, 76100
Novartis Investigative Site
Saint-Jean, 31240
Novartis Investigative Site
Saint-Priest-en-Jarez, 42270
Novartis Investigative Site
Saitnt Herblain, 44819
Novartis Investigative Site
Strasbourg, 67091
Novartis Investigative Site
Toulouse, 31077
Novartis Investigative Site
Tours, 37000
Novartis Investigative Site
Tours, 37044
Novartis Investigative Site
Vannes, 56000

Other trials in France

About this study

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Conditions: Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular, Diabetic Retinopathy
Being tested: ranibizumab
Medical subject headings: Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ranibizumabDrug
One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)

Study groups in NCT01908816
Study group	Role	What they receive
ranibizumab	Experimental	0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL. Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.
Measured: 24 months

Secondary outcomes (6)

Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
BCVA change for diseases affecting the macular area either through CNV or ME. BCVA is tested using the ETDRS (Early Treatment Diabetic Retinopathy Study), the Snellen or Monoyer scales. The three scales are designed to measure visual acuity. ETDRS score is expressed in letter, Snellen and Monoyer score in fraction. BCVA assessment is presented in ETDRS after conversion if collected in Snellen or Monoyer. (Monoyer converted to Snellen = 2 x (Monoyer fraction) and Snellen converted to approximate ETDRS letters = 1x log(Snellen fraction). ETDRS letter score was transformed in logMAR unit for statistical analysis (- LogMAR = -(ETDRS-85)/50). The worse ETDRS letter score is 0 (logMAR 2.3) and the best ETDRS letter score is 100 (logMAR -0.3).
Measured: 3 months, 12 months
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
The extent of iris neovascularization was assessed by iris photography and graded using the "Teich and Walsh grading system". This grading system measures the number of quadrant at iris pupillary zone or iris ciliary zone where iris neovascularization (NV) is observed.
Grade 0 = "No iris vascularization", Grade 1= Less than 2 quadrants of NV at iris pupillary zone, Grade 2 = More than 2 quadrants of NV at iris pupillary zone, Grade 3 =Grade 2 + less than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae; Grade 4 =More than 3 quadrants of NV at iris ciliary zone and/or ectropion uveae)
Measured: 3 month, 12 month
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Occurrence of postoperative vitreous cavity hemorrhage
Measured: 3 months, 12 month
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
CRT in micrometers assessed by Optical Tomography (OCT) at each single study visit. A reduction is thickness indicates an improvement is the lesion area
Measured: 3 months, 12 month
Proportion of Patients With Angiographic Leakage
Angiography was taken via fluorescein angiography. Any increases of angiographic leakage was counted between baseline and month 3. Also any decreases of angiographic leakage was counted between baseline and 3 month.
Measured: 3 months, 12 month
Ranibizumab Injection
Number of ranibizumab injections needed by decreased visual acuity and/or increasing retinal thickness in 3 months of observation period
Measured: 3 months, 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Sep 20138 Jan 2016

First posted26 Jul 2013 (estimated)
Study start26 Sep 2013
Primary completion8 Jan 2016
Study completion8 Jan 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Choroidal NeovascularizationStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 270 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01908816
Sponsor's protocol ID: CRFB002GFR02
Acronym: ECLIPSE
Status last verified: Jul 2019
First submitted: 20 Jul 2013
Last updated: 12 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

All Choroidal Neovascularization trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
ClinicalTrials.gov ID: NCT01908816
Acronym / sponsor ID: ECLIPSE / CRFB002GFR02
Conditions: Choroidal Neovascularization, Macular Edema, Glaucoma, Neovascular, Diabetic Retinopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 270 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Sep 2013 (actual)
Primary completion: 8 Jan 2016 (actual)
Study completion: 8 Jan 2016 (actual)
First posted: 26 Jul 2013 (estimated)
Results: Posted 12 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The pupose of this study is to evaluate the safety and the efficacy of ranibizumab in rare VEGF driven ocular diseases.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ranibizumab	Experimental	Drug: ranibizumab0.5 mg ranibizumab applied in an individualized regimen as IVT injection of 0.05 mL.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Active choroidal neovascularization (CNV)
Active macular edema (ME)
Rubeosis iridis/neovascular glaucoma.
Proliferative diabetic retinopathy requiring vitrectomy.

Key exclusion criteria (10 listed)

wet Age-related macular degeneration
pathologic myopia
pseudoxanthoma elasticum
diabetic macular edema
retinal vein occlusion

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ranibizumabOne injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)	Drug	ranibizumab

Primary outcome

Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 months
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs) for ocular and non-ocular events. Due to early termination, only descriptive analysis was conducted.

6 secondary outcomes

Change From Baseline Best Corrected Visual Acuity (BCVA) for Patients With Choroidal Neovascularization (CNV) and Macular Edema (ME)
Time frame: 3 months, 12 months
Average Change of Neovascularization Extension for Patients With Neovascular Glaucoma
Time frame: 3 month, 12 month
Proportion of Patient With Vitreous Cavity Hemorrhage Occurrence for Patient With Proliferative Retinopathy
Time frame: 3 months, 12 month
Mean Change From Baseline in Change in Central Retinal Thickness for Patients With CNV (Choroidal Neovascularization) and ME (Macular Edema)"
Time frame: 3 months, 12 month
Proportion of Patients With Angiographic Leakage
Time frame: 3 months, 12 month
Ranibizumab Injection
Time frame: 3 months, 12 month

Results and safety

Results posted to the registry on 12 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CNV (Choroidal Neovascularization)	93	0
ME (Macular Edema)	84	0
RI/NVG (Rubeosis Iridis and Neovacular Glaucoma)	58	0
PDR/V	35	0

Primary outcome: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: 24 months. Count of participants. Unit: Participants

Measure	CNV (Choroidal Neovascularization) n = 93	ME (Macular Edema) n = 84	RI/NVG (Rubeosis Iridis and Neovacular Glaucoma) n = 58	PDR/V n = 35
Non- serious adverse events	2	21	1	0
Serious adverse events	11	15	31	14
Death	1	0	7	1

Population analysed: Safety population: all patients who received at least one application of study treatment and had at least one post-baseline safety assessment. The statement that a patient had no adverse events also constituted a safety assessment. All safety evaluations were carried out on the safety population.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 3 years. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Choroidal Neovascularization	11 of 93 (11.8%)	46 of 93 (49.5%)	1 of 93
Macular Edema	15 of 84 (17.9%)	66 of 84 (78.6%)	0 of 84
Rubeosis Iridis/ Neovascular Glaucoma	31 of 58 (53.4%)	40 of 58 (69%)	7 of 58
Proliferative Diabetic Retinopathy Requiring Vitrectomy	14 of 35 (40%)	21 of 35 (60%)	1 of 35

Limitations and caveats (from the sponsor): As the study was early terminated, no conclusion could be drawn from this study. The data should be interpreted with cautious as less than half of the patients included in the study (47.0%) completed the visit at Month 12.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Choroidal Neovascularization

Not yet recruitingPhase 2
A Study to Evaluate the Efficacy and Safety of VIS-101 in Participants With Neovascular Age-Related Macular Degeneration
Neovascular Age Related Macular Degeneration(nAMD)
Active, not recruitingPhase 2
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
Neovascular Age-related Macular Degeneration
RecruitingPhase 2/3
A Clinical Trial of EYE201/MK-8748 in People With Macular Degeneration (MK-8748-002)
Macular Degeneration, Age-Related Macular Degeneration
Active, not recruiting
Speculum-Free Intravitreal Injection Using Cotton-Tipped Applicator Retraction: Pain, Procedure Time, Patient Satisfaction, and Safety
Neovascular Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema
Active, not recruitingPhase 1/2
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
Age-Related Macular Degeneration

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

39 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ranibizumab in people with Choroidal Neovascularization and Macular Edema, run by Novartis Pharmaceuticals at 39 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events as a Measure of Safety and Tolerability (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01908816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.