Trial Outcomes & Findings for Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME) (NCT NCT01135914)

Last Updated: 2014-10-23

Results Overview

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

241 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2014-10-23

Participant Flow

A total of 239 patients were enrolled in the study. An additional 2 patients were enrolled but were removed from the database because consent was not signed in accordance with GCP principles."

3 treatment arms: Group C - laser photocoagulation per ETDRS guidelines, Group B - ranibizumab intravitreal injections (3 monthly injections during loading phase, and subsequent treatments per protocol-defined criteria), or Group A - combination therapy, where decisions to treat with laser were independent of decisions to treat with ranibizumab.

Participant milestones

Participant milestones
Measure	Combination Therapy Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy Participants received Laser photocoagulation therapy only
Overall Study STARTED	78	80	81
Overall Study Intent to Treat (ITT) Population	73	75	72
Overall Study Safety Population	73	75	74
Overall Study COMPLETED	74	75	59
Overall Study NOT COMPLETED	4	5	22

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Therapy Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy Participants received Laser photocoagulation therapy only
Overall Study Withdrawal by Subject	1	3	6
Overall Study Lost to Follow-up	1	0	1
Overall Study Protocol Violation	0	0	3
Overall Study Lack of Efficacy	2	1	10
Overall Study Adverse Event	0	1	2

Baseline Characteristics

Safety, Efficacy and Cost-efficacy of Ranibizumab (Monotherapy or Combination With Laser) in the Treatment of Diabetic Macular Edema (DME)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy n=73 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=75 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=72 Participants Participants received Laser photocoagulation therapy only	Total n=220 Participants Total of all reporting groups
Age, Continuous	60.8 years STANDARD_DEVIATION 10.21 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.86 • n=7 Participants	62.8 years STANDARD_DEVIATION 9.44 • n=5 Participants	61.7 years STANDARD_DEVIATION 9.83 • n=4 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	33 Participants n=7 Participants	29 Participants n=5 Participants	88 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	42 Participants n=7 Participants	43 Participants n=5 Participants	132 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. patients with both baseline and 12 month data were included.

Outcome measures

Outcome measures
Measure	Combination Therapy n=70 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=71 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=62 Participants Participants received Laser photocoagulation therapy only
Mean Change From Baseline in Best Corrected Visual Acuity- (BCVA) at Month 12	8.2 Letters Standard Deviation 9.20	8.9 Letters Standard Deviation 7.78	0.3 Letters Standard Deviation 12.47

SECONDARY outcome

Timeframe: Baseline, 3, 6 and 9 months

Population: The ITT population was defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one site were excluded from ITT.

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS)is 0 to 100 letters. A positive change from baseline of BCVA indicates improvement.

Outcome measures

Outcome measures
Measure	Combination Therapy n=73 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=75 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=72 Participants Participants received Laser photocoagulation therapy only
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 Month 3 (n=71, 75, 69)	3.7 Letters Standard Deviation 10.71	5.3 Letters Standard Deviation 7.58	1.4 Letters Standard Deviation 6.55
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 Month 6 (n= 70, 72, 65)	5.6 Letters Standard Deviation 8.45	7.1 Letters Standard Deviation 7.74	0.9 Letters Standard Deviation 7.23
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Months 3,6 and 9 Month 9 (n=69, 71, 59)	7.1 Letters Standard Deviation 7.92	6.9 Letters Standard Deviation 12.45	-0.2 Letters Standard Deviation 10.71

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9 and 12 months

OCT is a diagnostic imaging technique using low-coherence interferometry to produce cross-sectional tomograms of the posterior segment eye structures. OCT was performed prior to study treatment to assess CRT, presence of fluid in the macula (intra-retinal cyst or fluid) and evaluation of image to monitor disease progression/treatment effect and to determine the need to stop/re-initiate ranibizumab treatment

Outcome measures

Outcome measures
Measure	Combination Therapy n=73 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=75 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=72 Participants Participants received Laser photocoagulation therapy only
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Baseline	422.1 um Standard Deviation 142.26	448.5 um Standard Deviation 136.64	458.0 um Standard Deviation 133.07
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Month 3 (n=71,75, 69)	-105.7 um Standard Deviation 127.74	-108.9 um Standard Deviation 113.38	-32.5 um Standard Deviation 114.15
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Month 6 (n= 70,72,65)	-114.2 um Standard Deviation 110.88	-129.3 um Standard Deviation 116.50	-64.4 um Standard Deviation 110.77
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Month 9 (69,70,58)	-138.1 um Standard Deviation 125.86	-135.9 um Standard Deviation 140.90	-85.8 um Standard Deviation 128.00
Change From Baseline in Central Retinal Thickness (CRT) at Months 3,6,9 and 12 Month 12 (70,71,61)	-152.2 um Standard Deviation 139.27	-143.5 um Standard Deviation 143.95	-107.1 um Standard Deviation 143.86

SECONDARY outcome

Timeframe: Baseline, 3, 6, 9 and 12 months

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A higher percent of patients achieving a gain of ≥15 letters BCVA indicates a better response.

Outcome measures

Outcome measures
Measure	Combination Therapy n=73 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=75 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=72 Participants Participants received Laser photocoagulation therapy only
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline Month 3 (n=71,75,69)	8.5 Percentage of Patients	9.3 Percentage of Patients	2.9 Percentage of Patients
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline Month 6 (n=70,72,65)	11.4 Percentage of Patients	13.9 Percentage of Patients	1.5 Percentage of Patients
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline Month 9 (69,71,59)	13.0 Percentage of Patients	21.1 Percentage of Patients	0 Percentage of Patients
Percentage of Patients Achieving a Gain of 15-letters or More (3-lines) in BCVA From Baseline Month 12 (70,71,62)	24.3 Percentage of Patients	21.1 Percentage of Patients	6.5 Percentage of Patients

SECONDARY outcome

Timeframe: 12 months

Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (EDTRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of BCVA (EDTRS) is 0 to 100 letters. A gain of 5,10,15 or more BCVA letters from baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Combination Therapy n=70 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=71 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=62 Participants Participants received Laser photocoagulation therapy only
Percentage of Patients Achieving Gain of Letters From Baseline in BCVA 5 letter gain	61.4 Percentage of Patients	70.4 Percentage of Patients	40.3 Percentage of Patients
Percentage of Patients Achieving Gain of Letters From Baseline in BCVA 10 letter gain	34.3 Percentage of Patients	52.1 Percentage of Patients	16.1 Percentage of Patients
Percentage of Patients Achieving Gain of Letters From Baseline in BCVA 15 letter gain	24.3 Percentage of Patients	21.1 Percentage of Patients	6.5 Percentage of Patients

SECONDARY outcome

Timeframe: 12 month

Population: ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included

The National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) was used to measure the influence of visual disability and visual symptoms on general health domains. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. For each question, the patient was asked to rate their condition on a scale of 1-5 or 1-6, where a low number reflects a better outcome. A composite score for a patient is calculated by aggregating and averaging the scores from the 11 sub-scales (excluding general health sub-scale), and an algorithm is apply to give equal weight to each sub-scale. Sub-scales and composite scores are calculated by converting the response from questionnaires into a 0-100 scale, with 0 as the worst possible outcome and 100 as the best. Missing data was not imputed

Outcome measures

Outcome measures
Measure	Combination Therapy n=70 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=71 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=62 Participants Participants received Laser photocoagulation therapy only
National Eye Institute Visual Functioning Questionnaire - 25 (VFQ-25) Composite Score at Month 12	85.21 Units on a Scale Standard Deviation 12.77	84.29 Units on a Scale Standard Deviation 11.78	78.20 Units on a Scale Standard Deviation 17.27

SECONDARY outcome

Timeframe: 12 month

Population: ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included

The Euro Quality of Life Questionnaire (EQ-5D) standardized instrument was utilized to measure health outcomes related to 5 dimensions, namely: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. The possible range for each dimension was 1 to 3, where 1="no problems", 2="some problems" and 3="extreme problems". Missing values were not imputed. Using the scoring algorithm derived from the Canadian value sets (Bansback et al., 2012), a utility score for a patient was calculated based on the EQ-5D responses for a given time-point at which the questionnaire was presented to the patient. This mean EQ-5D utility score ranged between 0 (worst health) to 1 (perfect health).

Outcome measures

Outcome measures
Measure	Combination Therapy n=68 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=71 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=60 Participants Participants received Laser photocoagulation therapy only
EuroQoL (EQ-5D) Utility Score at Month 12	0.88 Units on a scale Standard Deviation 0.15	0.88 Units on a scale Standard Deviation 0.17	0.87 Units on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: 12 month

Population: ITT defined as all patients receiving at least one dose of either study treatment for monotherapy treatment arms, or one of the two study treatments for the combination therapy arm, and having at least 1 post-baseline assessment. Patients from one study site were excluded from ITT. Patients with both baseline and 12 month data were included

(TTO) questionnaire was used to help determine the patients' health utility. Reported health utility represents the patients' quality of life at the current health state, and is a cardinal value that ranges from 0 (worst possible health or death) to 1 (best possible health). In this questionnaire, patients were first asked to estimate their remaining life expectancy. Second, the patients were presented with a hypothetical situation where a technology existed that could permanently return their vision to normal. This technology would always work, but would decrease their length of survival. Patients were then asked how much of their remaining life expectancy, if any, they would be willing to trade in return for use of the technology and thus for normal vision. The principle of this measure is that if patients were content with their current vision status (i.e., have a utility value of 1.0), they would not want to trade any of their remaining life years to improve their vision.

Outcome measures

Outcome measures
Measure	Combination Therapy n=69 Participants Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=68 Participants Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=60 Participants Participants received Laser photocoagulation therapy only
Time Trade-Off Questionnaire - 25 (TTO) Composite Score at Month 12	0.83 Units on a scale Standard Deviation 0.28	0.78 Units on a scale Standard Deviation 0.23	0.80 Units on a scale Standard Deviation 0.24

Adverse Events

Combination Therapy

Serious events: 9 serious events

Other events: 26 other events

Deaths: 0 deaths

Ranibizumab Monotherapy

Serious events: 10 serious events

Other events: 26 other events

Deaths: 0 deaths

Laser Monotherapy

Serious events: 5 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Combination Therapy n=73 participants at risk Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.	Ranibizumab Monotherapy n=75 participants at risk Participants received ranibizumab intravitreal injection therapy only	Laser Monotherapy n=74 participants at risk Participants received Laser photocoagulation therapy only
Eye disorders Cataract (Fellow eye)	0.00% 0/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	6.7% 5/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	4.1% 3/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Cataract (Study eye)	0.00% 0/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	6.7% 5/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Conjunctival haemorrhage (Study eye)	12.3% 9/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	8.0% 6/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	1.4% 1/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Eye irritation (Study eye)	5.5% 4/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Vision blurred (Study eye)	5.5% 4/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Vitreous haemorrhage (Fellow eye)	5.5% 4/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	2.7% 2/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	1.4% 1/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Eye disorders Vitreous haemorrhage (Study eye)	1.4% 1/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	5.4% 4/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Infections and infestations Nasopharyngitis	6.8% 5/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	6.7% 5/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	5.4% 4/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Investigations Intraocular pressure increased (Fellow eye)	5.5% 4/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	5.3% 4/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	4.1% 3/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Investigations Intraocular pressure increased (Study eye)	11.0% 8/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	13.3% 10/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	5.3% 4/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Nervous system disorders Headache	1.4% 1/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	5.3% 4/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	1.4% 1/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Nervous system disorders Neuropathy peripheral	6.8% 5/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	1.3% 1/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	0.00% 0/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site
Vascular disorders Hypertension	2.7% 2/73 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	6.7% 5/75 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site	6.8% 5/74 The Safety population was defined as all patients who received at least 1 administration of ranibizumab/laser treatment for monotherapy, or at least one of the two treatments for combination therapy, excluding patients from one site

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until publication of the pooled data (i.e. data from all sites) in the clinical trial or dislcosure of trial results in their entirety.
Publication restrictions are in place

Restriction type: OTHER